Multi-arm tool for delivering implants and methods thereof

ABSTRACT

In a general aspect, a medical device includes a receiving arm configured to be coupled to at least a portion of an implant, and a clamping arm having a proximal end coupled to the receiving arm and having a track at a distal end of the clamping arm. The medical device also includes a sliding component including a needle and configured to slidably move along the track of the clamping arm.

CROSS REFERENCE TO RELATED APPLICATION

This application is a Nonprovisional of, and claims priority to, U.S.Provisional Application No. 61/530,511, filed on Sep. 2, 2011, entitled“A MULTI-ARM TOOL FOR DELIVERING IMPLANTS AND METHODS THEREOF”, which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates generally to medical devices and moreparticularly to medical devices that are configured to place or deliverimplants within a body of a patient.

BACKGROUND

A variety of medical procedures are performed to provide support toportions of a body of a patient. For example, some medical proceduresare performed to treat various pelvic dysfunctions, including proceduresto treat urinary incontinence, and correcting various prolapseconditions such as uterine prolapse, cystoceles, rectoceles, and vaginalvault prolapse.

Some such medical procedures have included placing implants within thepelvic region of the patient. Some of the implants are delivered to thepelvic region of the patient through one or more vaginal incisions,and/or through exterior incisions in the patient.

Often such implants are delivered or placed within the body of thepatient using an insertion or delivery tool. The insertion tools used todeliver the implants within a body of a patient typically include acurved portion and a sharp needle or point at one end. Some of theinsertion tools used to deliver the implants can be uncontrollable andcan deviate from the desired direction during the implantation process.Also, some of the insertion tools used to deliver the implants havelarge needles that can cause undesirable levels of trauma to tissuesduring the implantation process. Accordingly, complications, such asinadvertent tissue, nerve, bladder, or uretheral damage can occur duringthe implantation process. Such complications can also occur if the shapeor curvature of the insertion tool is inappropriate for delivering theimplant to the desired location within the body of the patient. Thus, itwould be desirable to provide an insertion tool that may be used todeliver an implant to a location within a body of a patient withoutdamaging tissue and/or adjacent nerves or organs in an undesirablefashion.

SUMMARY

In a general aspect, a medical device includes a receiving armconfigured to be coupled to at least a portion of an implant, and aclamping arm having a proximal end coupled to the receiving arm andhaving a track at a distal end of the clamping arm. The medical devicealso includes a sliding component including a needle and configured toslidably move along the track of the clamping arm.

In another general aspect, a medical device includes a receiving armconfigured to receive at least a portion of an implant, and a clampingarm coupled to the receiving arm and configured to move a track suchthat a distance between the track and the receiving arm is decreased.The medical device also includes a sliding component including a needleand configured to slidably move along the track such that the needle ismoved toward the receiving arm.

In yet another general aspect, a method includes inserting at least aportion of a receiving arm of a medical device coupled to at least aportion of an implant into a body of a patient, and moving a slidingcomponent along a track of a clamping arm such that a portion of aneedle of the sliding component is moved into the body of the patientand is coupled to the portion of the implant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a medical device.

FIG. 2A is a side view of a medical device in an open configuration.

FIG. 2B is a cross-sectional view of a sliding component and a track ofthe medical device shown in FIG. 2A.

FIG. 2C illustrates a coupling mechanism of a receiving of arm of themedical device shown in FIG. 2A.

FIG. 2D is a side view of the medical device shown in FIG. 2A in aclamped configuration.

FIG. 2E illustrates the sliding component of the medical device shown inFIG. 2A in a deployed configuration.

FIG. 2F is a zoomed in view of a needle coupled to the couplingmechanism of the receiving arm of the medical device shown in FIG. 2E.

FIG. 2G illustrates an implant portion coupled to a needle of themedical device shown in FIGS. 2A through 2F.

FIG. 3 is a schematic diagram of an implant, according to an embodiment.

FIG. 4A illustrates a medical device coupled to a syringe according toan embodiment.

FIG. 4B schematically illustrates the medical device shown in FIG. 4A inuse with a body of a patient.

FIG. 5 illustrates another medical device according to an embodiment.

FIG. 6 illustrates yet another medical device according to anembodiment.

FIGS. 7A, 7B, and 7C schematically illustrate implants disposed within abody of a patient.

FIG. 8 is a flow diagram that illustrates a method for using a medicaldevice.

FIG. 9 illustrates yet another medical device, according to anembodiment.

FIG. 10 illustrates yet another medical device, according to anembodiment.

FIGS. 11A through 11I illustrate yet another medical device 1100according to an embodiment.

DETAILED DESCRIPTION

The devices and methods described herein are generally directed toinsertion or delivery tools for placing implants within a body of apatient. The implants delivered with the insertion or delivery tools maybe used in any portion of a body of a patient. In some embodiments, theimplants include, but are not limited to, implants that are placedwithin a pelvic region of a patient. For example, the implants that maybe placed with the disclosed insertion or delivery tools includeposterior support implants, anterior support implants, and/or totalpelvic floor repair implants. Such implants can be placed into thepelvic space of a patient and secured at any of several locations withinthe pelvic space to treat many different pelvic floor dysfunctions. Forexample, an implant can be secured to a sacrospinous ligament or aureterosacral ligament for uterine preservation (e.g., if a prolapseduterus is otherwise healthy, a hysterectomy is not preformed and theuterus is re-suspended with an implant), or for posterior support. Inanother embodiment, an implant can be secured to pubo-urethral tissue oran obturator muscle (e.g., internus or externus) and/or membrane (eachalso referred to herein as “obturator”) to treat, for example,incontinence. In yet another embodiment, an implant can be secured to asacrospinous ligament or an arcus tendineus fascia pelvis (i.e., whiteline) (also referred to herein as “arcus tendineus”) for paravaginalrepairs including, for example, cystoceles, rectoceles and enteroceles.An implant can also be secured to various combinations of suchlocations. The insertion tools, implants, and procedures describedherein may be used in a female patient and/or a male patient.

In some embodiments, the disclosed insertion or delivery tool(s) may beused to place an implant, for example, through a vaginal incision, in aretro-pubic direction (behind the pubic bone), or in a pre-pubicdirection (in front of the pubic bone). In other embodiments, an implantcan be placed in the direction of other anatomical structures or tissuesas desired. A procedure to deploy a pelvic implant can include vaginalincisions, such as an anterior vaginal incision and/or a posteriorvaginal incision. In some embodiments, a procedure may include anexterior incision.

As used herein, the terms proximal portion or proximal end refer to theportion or end, respectively, of a device that is closest to a physicianwhen performing a medical procedure, and the terms distal portion ordistal end refer to the portion or end, respectively, of the device thatis furthest from the physician during a medical procedure. For example,a distal end or portion of an insertion tool or device as describedherein refers to the end or portion of the device that is first insertedinto a body of a patient during a medical procedure. The proximal end orportion is the end or portion of the device that is remains outside ofthe body of the patient during the insertion procedure (or if the entiredevice is inserted into the body of the patient during the deliveryprocedure, the proximal end portion is inserted into a body of thepatient after the distal end or distal portion is inserted). The terms“trailing end” and “leading end” are also referred to herein and havesimilar meanings as proximal and distal, respectively. As used herein,the term “leading end” refers to the end of a device or apparatus thatis inserted into a body first. The term “trailing end” refers to the endof the device or apparatus that remains outside of the body of thepatient or is inserted into the body after the leading end.

Various embodiments of insertion or delivery tools are described herein.The insertion or delivery tool may be used to deliver a variety ofdifferent implants into the body of a patient and only some examples ofimplants are described herein.

FIG. 1 is a schematic diagram of a medical device 100. The medicaldevice 100 is configured to be used as an insertion tool or deliverytool to implant or insert a bodily implant (not shown) into a body of apatient. In some embodiments, the medical device 100 is configured to beused to insert an implant into a body of a patient (e.g., a femalepatient, a male patient) using an outside-in approach (e.g., anoutside-in approach via a vaginal incision in the body of the patient,an outside-in approach via a rectal incision in the body of thepatient). The medical device 100 may be used to insert any type ofimplant into a body of a patient. In some embodiments, the medicaldevice 100 can be configured to place an implant into a pelvic region ofa patient. Specifically, in some embodiments, the medical device 100 isconfigured to place an implant through an obturator muscle and/or amembrane of a patient.

As shown in FIG. 1, the medical device 100 has a receiving arm 110 and aclamping arm 120. The clamping arm 120 is coupled (e.g., movablycoupled, slidably coupled, rotatably coupled, hingedly coupled) to thereceiving arm 110 so that the clamping arm 120 and the receiving arm 110can be moved towards one another. Specifically, in this embodiment, aproximal portion 122 of the clamping arm 120 is rotatably coupled to aproximal portion 112 receiving arm 110 to collectively define a hingeportion 104 of the medical device 100. As shown in FIG. 1, the receivingarm 110 and the clamping arm 120 are rotatably coupled (e.g., hingedlycoupled using a pin, a screw, and/or so forth) about an axis E (comingout of the figure).

As shown in FIG. 1, the clamping arm 120 can be moved (e.g., rotatablymoved) in a direction A1 (e.g., a counterclockwise direction) toward thereceiving arm 110 and/or the receiving arm 110 can be moved (e.g.,rotatably moved) in a direction A2 (e.g., a clockwise direction) towardthe clamping arm 120 so that a distance between at least a portion ofthe receiving arm 110 and at least a portion of the clamping arm 120 isdecreased (e.g., decreased to approximately 3 inches (3.81 centimeters(cm)), decreased to less 4 inches (10.16 cm), decreased to less 2 inches(5.08 cm)). The clamping arm 120 can be moved (e.g., rotatably moved) inthe direction A2 (e.g., clockwise direction) away from the receiving arm110 and/or the receiving arm 110 can be moved (e.g., rotatably moved) inthe direction A1 (e.g., counterclockwise direction) away from theclamping arm 120 so that a distance between at least a portion of thereceiving arm 110 and at least a portion of the clamping arm 120 isincreased (e.g., increased to greater than 1.5 inches (3.81 cm),increased to greater 2 inches (5.08 cm), increased to greater 4 inches(10.16 cm), increased to approximately 5 inches (12.7 cm)).

In the embodiment shown in FIG. 1, the medical device 100 is in an openconfiguration. The medical device 100 can be moved from the openconfiguration to a clamped configuration (or closed configuration) bymoving the clamping arm 120 toward the receiving arm 110 (or viceversa). After being moved to the clamped configuration, the medicaldevice 100 can be moved from the clamped configuration (or closedconfiguration) to the open configuration by moving the clamping arm 120away from the receiving arm 110 (or vice versa).

As shown in FIG. 1, a distal portion 124 of the clamping arm 120includes a sliding component 140 configured to slidably move on a track130 (which can be referred to as a track portion or as a track portionof the clamping arm 120) of the clamping arm 120. The sliding component140 is coupled to (or includes) a needle 160 configured to slidably movewithin a lumen 152 within a guide 150 (the guide 150 can be referred toas a guide portion). In some embodiments, the needle 160 can have adistal portion 162, and the distal portion 162 can have a distal tip164. The sliding component 140 is configured to slidably move indirection B1 along the track 130 so that a sliding component 140 ismoved toward the guide 150. The sliding component 140 is also configuredto slidably move in direction B2 (after being moved in direction B1)along the track 130 so that the sliding component is moved away from theguide 150.

The receiving arm 110 includes a coupling mechanism 170 on a distalportion 114 the receiving arm 110. At least a portion of an implant (notshown) configured to be inserted into a body of a patient can be coupledto the coupling mechanism 170. In some embodiments, the couplingmechanism 170 can be, or can include, an opening, a slot, a hook, alatch, a recess, and/or so forth. In some embodiments, the slot can be,for example, an L-shaped slot or a T-shaped slot.

The sliding component 140 (and needle 160) as illustrated in FIG. 1, isin a stowed configuration. The sliding component 140 can be moved fromthe stowed configuration to a deployed configuration (not shown) whenthe sliding component 140 is moved in direction B1 along the track 130.The sliding component 140 can be moved from the deployed configurationto the stowed configuration by slidably moving the sliding component 140in direction B2 along the track away from the guide 150.

When in the stowed configuration, a distal portion 162 of the needle 160is disposed within (e.g., in a position disposed within) the lumen 152of the guide 150 or is in a position proximal to (on the right side of)the guide 150. When in the deployed configuration, the distal portion162 of the needle 160 is moved outside of (e.g. is moved to positionoutside of) the lumen 152 of the guide 150 so that the distal portion162 of the needle 160 is distal to (on the left side of) the guide 150.In some embodiments, the stowed configuration can be referred to as arefracted configuration, and the deployed configuration can be referredto as an extended configuration.

In some embodiments, the sliding component 140 (and needle 160) can havemany different deployed configurations and stowed configurations. Forexample, the sliding component 140 (and needle 160) can be moved alongdirection B1 from a first deployed configuration to a second deployedconfiguration. A portion of the needle 160 disposed outside of the guide150 when in the first deployed configuration can be shorter than aportion of the needle 160 disposed outside of the guide 150 when thesliding component 140 is in the second deployed configuration. In someembodiments, the sliding component 140 (and the needle 160) can be movedalong direction B2 from the second deployed configuration to the firstdeployed configuration. As another example, the sliding component 140(and the needle 160) can be moved along direction B2 from a first stowedconfiguration to a second stowed configuration. The distal portion 162of the needle 160 may be disposed within the guide 150 when the slidingcomponent 140 is in the first stowed configuration and the distalportion 162 of the needle 160 may be disposed in a proximal positionoutside of the guide 150 when the sliding component 140 is in the secondstowed configuration. In some embodiments, the sliding component 140(and the needle) can be moved along direction B1 from the second stowedconfiguration to the first stowed configuration.

The sliding component 140 (and needle 160) can be configured so that thesliding opponent 140 can be moved between stowed configurations and/ordeployed configurations when the medical device 100 is in the clampedconfiguration (or closed configuration) or the open configuration. Forexample, the medical device 100 can be moved from an open configurationto a clamped configuration, while the sliding component 140 is in astowed configuration. After the clamping arm 120 is moved toward thereceiving arm 110 along direction A1 (or the receiving arm 110 is movedtoward the clamping arm 120 along direction A2) so that the medicaldevice 100 is in the clamped configuration (or closed configuration),the sliding component 140 (and needle 160) can be slidably moved alongdirection B1 from the stowed configuration to a deployed configuration.As another example, the medical device 100 can be moved from a clampedconfiguration to an open configuration while the sliding component 140is in a deployed configuration. After the clamping arm 120 is moved awayfrom the receiving arm 110 along direction A2 so that the medical device100 is in the open configuration, the sliding component 140 (and needle160) can be slidably moved along direction B2 from the deployedconfiguration to a stowed configuration.

In some embodiments, when the sliding component 140 is in the deployedconfiguration, at least a portion of the needle 160 (e.g., the distalportion 162 of the needle 160) can contact, or can be moved intorelatively close proximity, to at least a portion of the receiving arm110. In some embodiments, when the sliding component 140 is in thedeployed configuration, at least a portion of the needle 160 can contactand/or can be moved inside of at least a portion of the couplingmechanism 170 of the receiving arm 110. For example, if the couplingmechanism 170 defines, or includes, a cavity, at least a portion of theneedle 160 can be moved inside of the cavity when the sliding component140 is in the deployed configuration.

In some embodiments, when the sliding component 140 is in the deployedconfiguration, at least a portion of the needle 160 (e.g., at least aportion of the distal portion 162 of the needle 160) can contact and/orcan be coupled to (e.g., can engage) at least a portion of an implantcoupled to the coupling mechanism 170 of the receiving arm 110.Specifically, the needle 160 can have a coupling mechanism 166 at adistal portion 162 of the needle 160. In some embodiments, the couplingmechanism 166 can be, or can include, an opening, a slot, a hook, alatch, a recess, and/or so forth. In some embodiments, the slot can be,for example, an L-shaped slot or a T-shaped slot.

For example, when the sliding component 140 is moved to the deployedconfiguration (and the medical device 100 is in the clampedconfiguration), the coupling mechanism 166 of the distal portion 162 ofthe needle 160 can be coupled to an implant coupled to the couplingmechanism 170 of the receiving arm 110. When the sliding component 140is moved to the stowed configuration after coupling mechanism 166 of thedistal portion 162 is coupled to the implant, the implant can bedecoupled from (e.g., extracted from, removed from) the couplingmechanism 170 of the receiving arm 110. In some embodiments, the slidingcomponent 140 can be moved to the deployed configuration to retrieve theimplant from the coupling mechanism 170 of the receiving arm 110. Insome embodiments, the sliding component 140 of the clamping arm 120 canbe moved to the deployed configuration to retrieve at least a portion ofan implant coupled to the coupling mechanism 170 of the receiving arm110 after the medical device 100 is moved to the clamped configuration.

In some embodiments, the coupling mechanism 166 of the distal portion162 can be actuated, or triggered to be actuated, so that the couplingmechanism 166 can be coupled to the implant. In some embodiments, thecoupling mechanism 170 can be actuated, or triggered to be actuated, torelease the implant from the coupling mechanism 170.

In some embodiments, the distal tip 164 of the needle 160 can beconfigured to cut or pierce a bodily tissue. For example, in someembodiments, the distal tip 164 can include a sharp portion. In someembodiments, the distal tip 164 can define a blunt end. In someembodiments, the distal tip 164 can define a dilating end configured todilate a tissue of a patient.

As mentioned above, in some embodiments, the medical device 100 may beused to insert an implant (e.g., a surgical implant) (not shown) into apelvic region of a patient. Specifically, the medical device 100 can beused to insert an implant into a pelvic region of a patient using anoutside-in method.

First, the implant can be coupled to, or associated with, the couplingmechanism 170 included in the distal portion 114 of the receiving arm110 of the medical device 100. In some embodiments, the implant can becoupled to, or associated with, the coupling mechanism 170 of themedical device 100 when the medical device 100 is in the openconfiguration and/or when the medical device 100 is in the clampedconfiguration. An example of an implant that can be used with themedical device 100 is shown in connection with FIG. 3.

After the implant has been coupled to, or associated with, the couplingmechanism 170 of the receiving arm 110, the receiving arm 110 of themedical device 100 (e.g., at least a portion of the distal portion 114of the receiving arm 110) can be inserted into a body of a patient. Insome embodiments, the receiving arm 110 of the medical device 100 may beinserted into the pelvic region of the patient through an anteriorvaginal incision (i.e., via an outside-in approach). In someembodiments, the medical device 100 can be inserted into the body of thepatient such that the receiving arm 110 is moved along an edge of, or inclose proximity to, an edge of a bone (e.g., a pelvic bone) of thepatient.

In some embodiments, the medical device 100 can be in the openconfiguration (or moved to the open configuration) shown in FIG. 1 whenat least the distal portion 114 (which is coupled to or associated withthe implant) of the receiving arm 110 of the medical device 100 isinserted into the body of the patient. Specifically, the medical device100 can be in the open configuration shown in FIG. 1 so that theclamping arm 120 may remain outside of the body of the patient (e.g.,outside of a skin of the patient).

When the receiving arm 110 of the medical device 100 is inserted intothe body of the patient, the sliding component 140 can be in the stowedconfiguration. The sliding component 140 can be in the stowedconfiguration so that the distal tip 164 of the needle 160 may not comein contact with a bodily tissue of a patient (because the distal tip 164will be disposed within lumen 152 of the guide 150).

After the receiving arm 110 has been inserted into the body of thepatient, the medical device 100 can be moved to the clampedconfiguration. Specifically, the clamping arm 120 and the receiving arm110 can be moved towards one another so that a distance between, forexample, the track 130 and the coupling mechanism 170 may be decreased.When moved to the clamped configuration, the guide 150 of the clampingarm 120 of the medical device 100 may come in contact with the body ofthe patient. In some embodiments, a physician may apply a force (alongdirection A1) to the clamping arm 120 so that the medical device 100 canbe changed to the clamped configuration.

In some embodiments, the medical device 100 may be placed in a desirablelocation with respect to, for example an obturator muscle and/or anothertarget membrane of a patient before being moved to the clampedconfiguration. Specifically, the medical device 100 may be placed sothat the guide 150 may be disposed on one side of an obturator muscle(and/or another target membrane) of the patient and the couplingmechanism 170 (which is coupled to or associated with the implant) maybe disposed on another side of the obturator muscle (and/or anothertarget membrane) of the patient. Accordingly, when the sliding component140 is moved to the deployed configuration, the distal tip 164 of theneedle 160 will be slidably moved through the lumen 152 of the guide 150and pierce through the obturator muscle (and/or another target membrane)of the patient and toward the coupling mechanism 170.

After the medical device 100 (e.g., the receiving arm 110 and theclamping arm 120) is in a clamped configuration in a desirable locationaround, for example, the obturator muscle (and/or another targetmembrane) of the patient, the sliding component 140 can be moved fromthe stowed configuration to the deployed configuration (along directionB1) so that the distal tip 164 of the needle 160 can be deployed (e.g.,extended out of the lumen 152 of the guide 150) and pierce through theobturator muscle (and/or another target membrane). The distal tip 164 ofthe needle 160 may be moved until the coupling mechanism 166 is coupledto at least a portion of the implant (e.g., a tether of the implant,association members of the implant) coupled to, or associated with, thecoupling mechanism 170 of the receiving arm 110.

During a medical procedure, the coupling mechanism 170 of the receivingarm 110 (and the implant coupled thereto) may not be visible to aphysician using the medical device 100 when the coupling mechanism 170of the receiving arm 110 (and the implant coupled thereto) are disposedwithin the body of the patient. Even though the coupling mechanism 170of the receiving arm 110 (and the implant coupled thereto) may not bevisible to the physician using the medical device 100 when the slidingcomponent 140 is moved to the deployed configuration, the track 130and/or the guide 150 may be collectively configured so that the couplingmechanism 166 of the needle 160 may be coupled to at least a portion ofthe implant in a desirable fashion. In some embodiments, the needle 160may be configured (e.g., configured with a stiffness) so that thecoupling mechanism 166 of the needle 160 coupled to at least a portionof the implant without deflecting away from the implant in anundesirable way.

After the coupling mechanism 166 of the needle 160 is coupled to atleast the portion of the implant (e.g., the tether of the implant,association members of the implant), the sliding component 140 can bemoved in direction B2 from the deployed configuration to a stowedconfiguration so that the portion of the implant may be withdrawn fromthe body of the patient. In other words, the coupling mechanism 166 ofthe needle 160 can be retracted, while coupled to the implant (or atleast a portion thereof). Thus, the portion of the implant can beextracted from the coupling mechanism 170 of the receiving arm 110 andthe portion of the implant can be moved from a position inside of thebody of the patient to a position outside of the body of the patientusing the sliding component 140 of the clamping arm 120. The implant canbe decoupled from (e.g., extracted from, removed from) the couplingmechanism 166 by, for example, a physician after the sliding component140 is moved to the stowed configuration.

Although the portion of the implant is withdrawn from body of thepatient, another portion of the implant (e.g., a sling portion of theimplant) may remain within the body of the patient. In some embodiments,the portion of the implant withdrawn from the body of the patient may beused to adjust a location and/or tension of the portion of the implantremaining within the body of the patient.

Because certain tissues of a patient (e.g., an obturator muscle) can berelatively stiff and/or relatively difficult to pierce, the guide 150 ofthe clamping arm 120 can function as a support for the needle 160 as thedistal tip 164 is moved through the tissue(s). Specifically, the guide150 of the clamping arm 120 can be made of a relatively rigid materialthat can prevent (or substantially prevent) the needle 160 from bendingin an undesirable fashion. In some embodiments, the guide 150 cansupport the needle 160 while the distal tip 164 is moved through atissue so that the needle 160 may not be deformed inelastically. Becausethe distal end (e.g., left side) of the guide 150 can be contacting orclose to tissue that will be pierced by at least a portion of the distaltip 164 of the needle 160, a length of the portion of the distal portion162 can be zero, or nearly zero, when the distal tip 164 contacts thetissue as the sliding mechanism 140 is moved to the deployedconfiguration.

The track 130 is configured so that the sliding component 140 can beslidably moved on the track 130. In some embodiments, the track 130 canbe, or can include, a slot or groove into which the sliding component140 can be inserted and slidably moved. In some embodiments, the track130 can include a member (e.g., a rod) along which the sliding component140 can slidably move. In some embodiments, at least a portion of thesliding component 140 can be disposed around (e.g., at least partiallyaround), or otherwise coupled to, the member. In some embodiments, thesliding component 140 and/or the track 130 can include rolling devicessuch as wheels or ball-bearings that can facilitate translationalmovement (e.g., facilitate relatively smooth translational movement) ofthe sliding component 140 along the track 130. A cross-sectional view ofan example of a track is shown and described in connection with FIG. 2B.

In some embodiments, the needle 160 has a circular cross-sectional shape(or outer profile). In some embodiments, the needle 160 can have adifferent shape than a circular cross-sectional shape. In someembodiments, the needle 160 can have a cross-sectional shape (or outerprofile) of any type of polygon. For example, the needle 160 can have asquare or a rectangular cross-sectional shape (or outer profile). Insome embodiments, the needle 160 can have a tapered shaped and/or atapered portion (e.g., tapered from a proximal portion to a distalportion). In such embodiments, the needle 160 can have a varyingdiameter.

In some embodiments, the lumen 152 of the guide 150 can have across-sectional shape of any type of polygon. For example, the lumen 152can have a square or rectangular cross-sectional shape (or outerprofile) within which the needle 160 can be disposed. In someembodiments, the lumen 152 can have a tapered shaped and/or a taperedportion (e.g., tapered from a proximal portion to a distal portion).

In some embodiments, the needle 160 has a portion of a surface with across-sectional shape (or outer profile) that matches a portion of aninner surface of the lumen 152 of the guide 150. In some embodiments,the needle 160 can have a shape that does not match (e.g., is differentfrom) a cross-sectional shape of the lumen 152 of the guide 150.

As shown in FIG. 1, clamping arm 120 is aligned along a longitudinalaxis Q1 and the receiving arm 110 is aligned along a longitudinal axisQ2. As shown in FIG. 1, an acute angle is defined by the longitudinalaxis Q1 of clamping arm 120 and the longitudinal axis Q2 of receivingarm 110 when the medical device 100 is in the open configuration. Asecond acute angle, that is smaller than the first acute angle, isdefined by the longitudinal axis Q1 of clamping arm 120 and thelongitudinal axis Q2 of the receiving arm 110 when the clamping arm 120is moved towards the receiving arm 110 to define the clampedconfiguration of the medical device 100. Thus, an angle betweenlongitudinal axis Q1 of the clamping arm 120 and the longitudinal axisQ2 of the receiving arm 110 decreases when the medical device 100 ismoved from the open configuration to the clamped configuration. Itfollows that the angle between longitudinal axis Q1 of the clamping arm120 and the longitudinal axis Q2 of the receiving arm 110 increases whenthe medical device 100 is moved from the clamped configuration to theopen configuration. Thus, the medical device 100 can be reversibly movedto/from the clamped configuration or the open configuration.

Although not shown in FIG. 1, in some embodiments, the medical device100 can have one or more locking mechanisms configured to removably(e.g., releasably) lock the medical device 100 into one or more clampedconfigurations and/or one or more open configurations. In someembodiments, the medical device 100 can also have one or more lockingmechanisms configured to removably lock the sliding component 140 intoone or more stowed configurations and/or one or more deployedconfigurations along the track 130. More details related to lockingmechanisms are discussed in connection with, for example, FIGS. 4through 6.

In some embodiments, movement of the sliding component 140 along thetrack 130 may be limited based on a position of the receiving arm 110with respect to the clamping arm 120. For example, the movement of thesliding component 140 along the track 130 may be limited to a particularposition along the track 130 when the medical device 100 is in aparticular clamped configuration. More details related to movement of asliding component being limited are discussed in connection with, forexample, FIGS. 5 and 6.

In some embodiments, the medical device 100 can include an indicatormechanism configured to indicate a position of at least a portion of thereceiving arm 110 with respect to a portion of the clamping arm 120. Forexample, the medical device 100 can include an indicator mechanismconfigured to indicate that the distal tip 164 of the needle 160 isdisposed within the coupling mechanism 170 when the sliding component140 is in a specified position along the track 130. As another example,medical device 100 can include an indicator mechanism configured torepresent a distance (e.g., relative distance) between at least aportion of the receiving arm 110 (e.g., the coupling mechanism 170 ofthe receiving arm 110) and at least a portion of the clamping arm 120(e.g., a distal portion of the track 130). In some embodiments, becausethe coupling mechanism 170 of the receiving arm 110, and an implantcoupled thereto, may not be visible to the physician when using themedical device 100, the medical device 100 can include one or moreindicators (and/or indicator mechanisms) configured to assist aphysician in inserting the implant into a body of a patient in adesirable fashion. More details related to indicators are described inconnection with, for example, FIGS. 5 and 6.

Although not shown in FIG. 1, in some embodiments, the medical device100 can be configured so that the medical device 100 is biased towardsone or more open configurations (such as the open configuration shown inFIG. 1) or one or more the clamped configuration. In such embodiments, abiasing mechanism such as a spring mechanism, a gear mechanism, and/orso forth, can be disposed between receiving arm 110 (or a portionthereof) and clamping arm 120 (or portion thereof) to cause the medicaldevice 100 to be biased toward one or more open configurations and/orone or more clamped configurations. In some embodiments, the biasingmechanism can be coupled to the medical device 100 at, or around, thehinge portion 104.

If biased toward the open configuration, a force (e.g., a constantforce) may be applied (e.g., applied against the receiving arm 110and/or the clamping arm 120) to move the receiving arm 110 and theclamping arm 120 towards one another so that the medical device 100 canbe changed to the clamped configuration. When the force is no longerapplied, the receiving arm 110 and the clamping arm 120 can be movedaway from one another by the biasing mechanism.

If biased towards the clamped configuration, a force (e.g., a constantforce) may be applied (e.g., applied against the receiving arm 110and/or the clamping arm 120) to move the receiving arm 110 in theclamping arm 120 away from one another so that the medical device 100can be changed to the open configuration. When the force is no longerapplied, the receiving arm 110 and the clamping arm 120 can be movedtowards one another in response to the biasing mechanism.

Although not shown in FIG. 1, in some embodiments, the sliding component140 can be configured so that the sliding component 140 is biased towardone or more stowed configurations (such as the stowed configurationshown in FIG. 1) or one or more deployed configurations. In suchembodiments, a biasing mechanism such as a spring mechanism, a gearmechanism, and/or so forth, can be coupled to the track 130, the slidingcomponent 140, the guide 150, and/or so forth. As a specific example,the spring may be disposed between the sliding component 140 and theguide 150 to cause the sliding component 140 to be biased towards thestowed configuration shown in FIG. 1.

If biased towards the stowed configuration, a force (e.g., a constantforce) may be applied (e.g., applied against the sliding component 140)to move the sliding component 140 along direction B1 towards the guide150 along the track 130 so that the sliding component 140 can be changedto the deployed configuration. When the force is no longer applied, thesliding component 140 can be moved back to the stowed configuration bythe biasing mechanism. Similarly, if biased towards the deployedconfiguration, a force (e.g., a constant force) may be applied (e.g.,applied against the sliding component 140) to move the sliding component140 along direction B2 away from the guide 150 along the track 130 sothat the sliding component 140 can be changed to the stowedconfiguration. When the force is no longer applied, the slidingcomponent 140 can be moved back to the deployed configuration by thebiasing mechanism.

In some embodiments, at least a portion of the needle 160 can be formedof a flexible material. For example, a portion of the needle 160 thatremains disposed within the guide 150 when in the stowed configurationand in the deployed configuration can be configured to flex or bend. Insome embodiments, at least a portion of the needle 160 that is made of aflexible material can be biased to a specified position and/orcurvature. In some embodiments, at least a portion of the needle 160 canbe formed of a flexible material so that a portion of the needle 160 canconform to a curvature of the guide 150 (e.g., a varying curvature), ifcurved, as the needle 160 is slidably moved within the guide 150.

The medical device 100, or portions thereof, can be made of varioustypes of materials such as a polymer-based material (e.g., apolycarbonate material), a metal (e.g., stainless steel), and/or soforth. In some embodiments, any portion of the medical device 100 can beformed of a biocompatible material. In some embodiments, needle 160 canbe formed of, for example, a polymer-based material, a stainless steelmaterial (e.g., surgical grade stainless steel), and/or so forth.

FIG. 2A is a side view of a medical device 200 in an open configuration.The medical device 200 is configured to be used as an insertion tool ordelivery tool to implant or insert a bodily implant (not shown) into abody of a patient. In some embodiments, the medical device 200 isconfigured to be used to insert an implant into a body of a patient(e.g., a male patient, a female patient) using an outside-in approach(e.g., an outside-in approach via a vaginal incision in the body of thepatient). The medical device 200 may be used to insert any type ofimplant into a body of a patient. In some embodiments, the medicaldevice 200 can be configured to place an implant into a pelvic region ofa patient. Specifically, in some embodiments, the medical device 200 isconfigured to place an implant through an obturator muscle and/or amembrane of a patient.

As shown in FIG. 2A, the medical device 200 has a receiving arm 210 anda clamping arm 220. The clamping arm 220 is coupled (e.g., rotatablycoupled, hingedly coupled) to the receiving arm 210 so that the clampingarm 220 and the receiving arm 210 can be moved towards one another.Specifically, a proximal portion 222 of the clamping arm 220 isrotatably coupled to a proximal portion 212 of the receiving arm 210 tocollectively define a hinge portion 204 of the medical device 200. Inthis embodiment, at least a portion of the proximal portion 222 of theclamping arm 220 is disposed inside of the receiving arm 210. In someembodiments, at least a portion of the proximal portion 212 of thereceiving arm 210 may be disposed inside of the clamping arm 220. Insome embodiments, a portion of the clamping arm 220 may not be disposedwithin a portion of the receiving arm 210.

As shown in FIG. 2A, the clamping arm 220 can be moved (e.g., rotatablymoved) in a counterclockwise direction Cl towards the receiving arm 210and/or the receiving arm 210 can be moved (e.g., rotatably moved) in aclockwise direction C2 towards from the clamping arm 220 so that adistance between at least a portion of the receiving arm 210 (e.g., acoupling mechanism 270 of the receiving arm 210) and at least a portionof the clamping arm 220 (e.g., a track 230 of the clamping arm 220) isdecreased. The clamping arm 220 can be moved (e.g., rotatably moved) ina clockwise direction C2 away from the receiving arm 210 and/or thereceiving arm 210 can be moved (e.g., rotatably moved) in acounterclockwise direction Cl away from the clamping arm 220 so that adistance between at least a portion of the receiving arm 210 (e.g., thecoupling mechanism 270 of the receiving arm 210) and at least a portionof the clamping arm 220 (e.g., the track 230 of the clamping arm 220) isincreased. As shown in FIG. 2A, the receiving arm 210 and the clampingarm 220 are hingedly coupled (e.g., hingedly coupled using a pin, ascrew, and/or so forth) about an axis H (coming out of the figure).

FIG. 2D is a side view of the medical device 200 shown in FIG. 2A in aclamped configuration. The medical device 200 can be moved from the openconfiguration shown in FIG. 2A to a clamped configuration shown in FIG.2D by moving the clamping arm 220 toward the receiving arm 210 (and/orvice versa). In some embodiments, the medical device 200 can be moved tothe clamped configuration shown in FIG. 2D after at least a portion ofthe receiving arm 210 has been inserted into a body of a patient (e.g.,into a vaginal region of the patient) while the medical device 200 is inthe open configuration shown in FIG. 2A. In some embodiments, a distalportion of (e.g., a left portion of) the guide 250 may be pushed against(e.g., compressed against) a tissue (e.g., a skin layer) of the patientwhen the medical device 200 is moved to the clamped configuration afterthe portion of the receiving arm 210 has been inserted into the body ofthe patient. In some embodiments, the distal portion of the guide 250may be pushed to compress the tissue of the patient (disposed betweenthe receiving mechanism 270 and the guide 250) when the medical device200 is moved to the clamped configuration so that a distance that thedistal tip 264 travels (e.g., moves) when the sliding component 240 ismoved from the stowed configuration (shown in FIG. 2D) to the deployedconfiguration (shown in FIG. 2E) is shorter than a distance that thedistal tip 264 travels (e.g., moves) when the sliding component 240 ismoved from the stowed configuration to the deployed configuration if thetissue of the patient is not compressed when the medical device 200 isin the clamped configuration. After being moved to the clampedconfiguration, the medical device 200 can be moved from the clampedconfiguration (shown in FIG. 2D) to the open configuration (shown inFIG. 2A) by moving the clamping arm 220 away from the receiving arm 210(and/or vice versa).

As shown in FIG. 2A, a distal portion 224 of the clamping arm 220includes a sliding component 240 configured to slidably move along thetrack 230 (which can be referred to as a track portion) of the clampingarm 220. The sliding component 240 is coupled to (or includes) a needle260 configured to slidably move within a lumen 252 of a guide 250 (theguide 250 can be referred to as a guide portion). In some embodiments,the needle 260 can have a distal portion 262 and the distal portion 262can have a distal tip 264. The sliding component 240 is configured toslidably move in direction Dl along the track 230 so that a slidingcomponent 240 is moved toward the guide 250. The sliding component isalso configured to slidably move in direction D2 (after being moved indirection D1) along the track 230 so that the sliding component is movedaway from the guide 250.

FIG. 2B is a cross-sectional view of the sliding component 240 and thetrack 230 shown in FIG. 2A. Specifically the cross-sectional view shownin FIG. 2B is cut along the area Z. In this embodiment, the slidingcomponent 240 includes sliding members 244 that wrap at least partiallyaround the track 230 so that the sliding component 240 may remaincoupled to (e.g., may not become decoupled from) the track 230. Thetrack 230 has a top surface 232 along which the sliding component 240can slidably move. In some embodiments, the top surface 232 of the track230 can be a curved surface, a flat surface, and/or so forth. In someembodiments, the track 230 can have a cross-sectional shape (or outerprofile) of any type of polygon. For example, the track 230 can have asquare or a rectangular cross-sectional shape (or outer profile). Insome embodiments, the track 230 can have a tapered shaped and/or atapered portion (e.g., tapered from a proximal portion to a distalportion).

As shown in FIG. 2A, the track 230 and needle 260 are curved. As shownin FIG. 2A, the track 230 and the needle 260 have a concave curvaturearound the hinge portion 204 of the medical device 200. In other wordsthe concave portion (or inner surface of the concave portion) of thecurvature of the track 230 and the curvature of the needle 260 facetowards the hinge portion 204 of the medical device 200. Thus, a radiusof curvature of the track 230 and a radius of curvature of the needle260 is approximately aligned along a longitudinal axis of the clampingarm 220. Also, a radius of curvature of the track 230 and a radius ofcurvature of the needle 260 are on the same side as the hinge portion204 of the medical device 200. In this embodiment, the centroid of thetrack 230 and of the needle 260 is approximately at the axis H where thereceiving arm 210 is hingedly coupled to the clamping arm 220. Thus, theradius of curvature of the track 230 extends between (e.g., extendsapproximately between) the track 230 and the axis H, and radius ofcurvature of the needle 260 extends between (e.g., extends approximatelybetween) the needle 260 and the axis H.

In some embodiments, the coupling mechanism 270 of the receiving arm 210can be aligned with the needle 260 and/or the sliding component 240 sothat the distal portion 262 (e.g., distal tip 264) of the needle 260will come into close proximity to (or will be inserted into) thecoupling mechanism 270 regardless of the position of (or over a range ofpositions of) the coupling mechanism 270 with respect to the slidingcomponent 250 and/or the needle 260. For example, the coupling mechanism270 (and the receiving arm 210) can be configured so that distal tip 264of the needle 260 may be moved into the coupling mechanism 270 when themedical device 200 is in the closed configuration and when the medicaldevice 200 is in the open configuration. In some embodiments, thecoupling mechanism 270 (and the receiving arm 210) can also beconfigured so that distal tip 264 of the needle 260 may be moved intothe coupling mechanism 270 when the medical device 200 is in aconfiguration between the closed configuration and the openconfiguration.

In some embodiments, the coupling mechanism 270 and the needle 260 (or aportion thereof) can be configured to move along a common curve (e.g.,arc, line). For example, as shown in FIG. 2D, the distal tip 264 and thecoupling mechanism 270 can be configured to move along the arc 60.Accordingly, when the coupling mechanism 270 is moved away from theguide 250 (when the receiving arm 210 is moved away from the clampingarm 220), the distal tip 264 of the needle 260 can still be movedtowards the coupling mechanism 270 (along the arc 60) using the slidingmechanism 240 into the cavity 272 of the coupling mechanism 270. Also,when the coupling mechanism 270 is moved toward the guide 250 (when thereceiving arm 210 is moved toward the clamping arm 220) the distal tip264 of the needle 260 can be moved towards the coupling mechanism 270(along the arc 60) using the sliding mechanism 240 into the cavity 272of the coupling mechanism 270.

In some embodiments, a centroid and/or axis of the track 230 and/or theneedle 260 can be separate from an axis around which the receiving arm210 and the clamping arm 220 are rotatably coupled. In other words, thereceiving arm 210 and the clamping arm 220 can be hingedly coupled at anaxis that is separate from a centroid of the track 230 and/or a centroidof the needle 260.

In this embodiment, the clamping arm 220 (and receiving arm 210), thesliding component 240, and the needle 260 can be configured to rotatablymove within a plane that is orthogonal to, or substantially orthogonalto, the axis H. The needle 260 can be disposed within the plane. In someembodiments, the radius of curvature of the track 230 and/or of theneedle 260 can be between, for example, 2.0 inches (5.08 cm) and 20inches (50.8 cm) (e.g., 10 inches (25.4 cm), 5 inches (12.7 cm)). Insome embodiments, the radius of curvature of the track 230 and/or of theneedle 260 can be less than 2.0 inches (5.08 cm), or can be greater than20 inches (50.8 cm).

As shown in FIG. 2A, the receiving arm 210 includes a coupling mechanism270 on a distal portion 214 the receiving arm 210. An implant portion 80configured to be inserted into a body of a patient is coupled to thecoupling mechanism 270. In some embodiments, the implant portion 80 canbe, for example, a tether coupled to a sling portion of an implant. Azoomed in view (area Y) of the coupling mechanism 270 and the implantportion 80 coupled to the coupling mechanism 270 is shown in FIG. 2C.

FIG. 2C illustrates the coupling mechanism 270 shown in FIG. 2A. Asshown in FIG. 2C, the coupling mechanism 270 includes slots 274 intowhich the implant portion 80 may be inserted. When the implant portion80 is inserted into the slots 274, a portion 82 of the implant portion80 spans between the slots 274. In some embodiments, the slots 274 canbe sized so that the implant portion 80 may be press fit into one ormore of the slots 274. Also as shown in FIG. 2C, the coupling mechanism270 defines a cavity 272. Although not shown in FIG. 2C, in someembodiments, the coupling mechanism 270 can also be, or can include, ahook, a latch, and/or so forth

Referring back to FIG. 2A, the coupling mechanism 270 is included in thedistal portion 214 of the receiving arm 210. Specifically, the couplingmechanism 270 is included at the end of a curved portion of thereceiving arm 210. In some embodiments, coupling mechanism may beincluded on a different portion of the receiving arm 210 such as amedial portion of the receiving arm 210.

The sliding component 240 (and needle 260) as illustrated in FIG. 2A, isin a stowed configuration. The sliding component 240 can be moved fromthe stowed configuration (shown in FIG. 2A) to a deployed configuration,shown in FIG. 2E, when the sliding component 240 is moved in directionDl along the track 230. The sliding component 240 can be moved from thedeployed configuration (shown in FIG. 2E) to the stowed configuration(shown in FIG. 2A) by slidably moving the sliding component 240 indirection D2 along the track away from the guide 250.

When in the stowed configuration shown in FIG. 2A, a distal portion 262of the needle 260 is disposed within (e.g., in a position disposedwithin) the lumen 252 of the guide 250 or is in a position proximal to(on the right side of) the guide 250. When in the deployed configurationshown in FIG. 2E, the distal portion 262 of the needle 260 is movedoutside of (e.g. is moved to position outside of) the lumen 252 of theguide 250 so that the distal portion 262 of the needle 260 is distal to(on the left side of) the guide 250. In this embodiment, the slidingcomponent 240 is slidably moved along the track 230 so that the slidingcomponent 240 is in the deployed configuration shown in FIG. 2E afterthe medical device 200 is moved to the clamped configuration shown inFIG. 2D.

In some embodiments, when the sliding component 240 is moved to thedeployed configuration, the distal tip 264 of the needle 260 will beslidably moved through the lumen 252 of the guide 250 and will pierce atissue of a patient (for example, if the receiving arm 210 of themedical device 200 is disposed within a body of the patient). Forexample, the distal tip 264 of the needle 260 can be configured topierce through a skin tissue, an obturator muscle, and/or another targetmembrane of the patient and toward the coupling mechanism 270 of thereceiving arm 210.

In this embodiment, when the sliding component 240 is in the deployedconfiguration shown in FIG. 2E, the distal tip 264, and at least aportion of the distal portion 262 of the needle 260 is moved into thecavity 272 of the coupling mechanism 270. The distal tip 264 is movedinto the cavity 272 of the coupling mechanism 270 so that a couplingmechanism 266 of the needle 260 may be coupled to (e.g., moved into,engaged with) the implant portion 80. In some embodiments, the couplingmechanism 266 can be, or can include, an opening, a slot, a hook, alatch, a recess, and/or so forth. A zoomed in view of the couplingmechanism 266 of the needle 260 being coupled to the implant portion 80within the coupling mechanism 270 of the receiving arm 210 is shown inFIG. 2F.

As shown in FIG. 2F, in this embodiment, the coupling mechanism 266 is aslot 267 into which the implant portion 80 is coupled when the distaltip 264, and at least a portion of the distal portion 262, of the needle260 is moved into the coupling mechanism 270. Specifically, the distaltip 264, the portion of the distal portion 262, of the needle 260 can bemoved along direction Dl into the cavity 272 of the coupling mechanism270 so that the distal tip 264 moves below the implant portion 80. Theportion 82 of the implant portion 80 that spans the slots 274 maycontact a distal surface 265 of the needle 260 as the distal tip 264 andthe portion of the distal portion 262 are moved into the couplingmechanism 270. The portion 82 of the implant portion 80 may be movedalong the distal surface 265 until the portion 82 of the implant portion80 is coupled with (e.g., moved into, engaged with) the couplingmechanism 266 of the needle 260. In some embodiments, the portion 82 ofthe implant portion 80 may be deflected upward and/or the distal endportion 262 of the needle 260 may be deflected downward as the distalsurface 265 of the needle 260 comes into contact with (e.g., contacts,slides along) the portion 82 of the implant portion 80.

During a medical procedure, the coupling mechanism 270 of the receivingarm 210 (and the implant portion 80 coupled thereto) may not be visibleto a physician using the medical device 200 when the coupling mechanism270 of the receiving arm 210 (and the implant portion 80 coupledthereto) are disposed within a body of a patient. Even though thecoupling mechanism 270 of the receiving arm 210 (and the implant portion80 coupled thereto) may not be visible to the physician using themedical device 200 when the sliding component 240 is moved to thedeployed configuration, the track 230 and/or the guide 250 may becollectively configured so that the distal tip 264 and the portion ofthe distal portion 262 may be moved into the coupling mechanism 270 in adesirable fashion. In some embodiments, the needle 260 may be configured(e.g., configured with a stiffness) so that the distal tip 264 of theneedle 260, and the portion of the distal portion 262, will be movedinto the coupling mechanism 270 without deflecting in an undesirablefashion.

FIG. 2G illustrates the implant portion 80 coupled to the needle 260 ofthe medical device 200 shown in FIGS. 2A through 2F. As shown in FIG.2G, the sliding component 240 is in a deployed configuration, but ismoved along direction D2 from the deployed configuration shown in FIG.2E. When the sliding component 240 is moved along direction D2 after thecoupling mechanism 266 of the needle 260 is coupled with the implantportion 80, the implant portion 80 is decoupled from the couplingmechanism 270 of the receiving arm 210.

Although not shown in FIG. 2G, the sliding component 240 may be movedalong direction D2 until the sliding component 240 is in a stowedconfiguration. In such embodiments, at least a portion of the implantportion 80 may be moved into the lumen 252 of the guide 250 whilecoupled to the coupling mechanism 266 of the needle 260. In someembodiments, at least a portion of the implant portion 80 may be moveduntil the portion of the implant portion 80 is disposed outside of thelumen 252 on a proximal side (e.g., the right side) of the guide 250while coupled to the coupling mechanism 266 of the needle 260. In someembodiments, as the sliding component 240 is moved along direction D2 atleast a portion of the implant portion 80 may be moved outside of thebody of the patient by the needle 260 and the sliding component 240.

Although not shown, in some embodiments, as the sliding component 240 ismoved along direction D2 at least a portion of the implant portion 80may be moved to a desirable position with the body of the patient by theneedle 260 and the sliding component 240. In such embodiments, theportion of the implant portion 80 can be released from the needle 260(using an actuating mechanism) so that the implant portion 80 may beplaced within the body of the patient.

In some embodiments, the needle 260 can define a lumen that isconfigured to convey fluids to and/or from a body of a patient. As shownin FIG. 2A, 2D, and 2E the sliding component 240 of the medical device200 has an opening 242 configured to be coupled to a fluid deliverydevice. The opening 242 can be in fluid communication with the lumen ofthe needle 260 so that a fluid can be delivered from the fluid deliverydevice via the opening 242 and into the lumen of the needle 260. Moredetails related to fluid delivery via the medical device 200 aredescribed in connection with FIG. 4.

Because the guide 250 can function as a support for the needle 260, theneedle 260 can have a cross-sectional area (along a plane orthogonal (orapproximately orthogonal) to a longitudinal axis of the needle 260) thatis smaller than would otherwise be permissible without the guide 250. Inother words, the needle 260 can be relatively thin (e.g., can have arelatively small diameter) because only a relatively short portion ofthe needle 260 may project from the guide 250 when the sliding component240 is in the deployed configuration. In some embodiments, the diameterof the needle 260 can be less than 3 millimeters (mm). For example, insome embodiments, the needle 260 can have a diameter of approximately2.5 mm. In some embodiments, the needle 260 can have a diameter lessthan 2.5 mm or a diameter greater than 2.5 mm. Also, because the guide250 can function as a support for the needle 260, the needle 260 canhave a curvature that is greater than (e.g., has a smaller radius ofcurvature) would otherwise be permissible without the guide 250. In someembodiments, the coupling mechanism 270 of the receiving arm 210 can bemoved so that the coupling mechanism 270 is contacting, or is relativelyclose to (e.g., less than 2 mm, less than 2 cm), a tissue through whichat least a portion of the needle 260 is to pierce (on the oppositeside).

The medical devices described herein (e.g., the medical devices 100 and200 shown in FIGS. 1 and 2) may be used to insert an implant into apelvic region of a patient. For example, an implant 300 as illustratedin FIG. 3 may be implanted into a pelvic region of a patient using themedical devices. The implant 300 shown in FIG. 3 is a sling and includesa support portion 310, end portions 320 and 330, and association members340 and 350. In some embodiments, the association members 340, 350 canbe tethers. The support potion 310 can be configured to be placedproximate a portion of the body of the patient and can be configured toprovide support to the portion of the body. The end portions 330 and 340can be configured to be placed into and coupled to bodily tissue toanchor the implant 300 within the body of the patient. The associationmembers 340 and 350 can be configured to associate the implant 300 tothe medical devices during an implantation procedure.

In some embodiments, the implant 300 may be formed of any biocompatiblematerial. In some embodiments, the implant 300 can be formed of a meshmaterial. For example, the implant 300 may be formed of Advantage® meshor the Polyform™ synthetic mesh, both as produced and/or sold by BostonScientific Corporation. In some embodiments, in the implant 300 may beformed of a polymer material. In some embodiments, the material of theimplant 300 allows for tissue in-growth to secure the implant 300 to thebodily tissue of the patient.

In some embodiments, the implant 300 can include tangs to help retainthe implant 300 in place within the body of the patient. In suchembodiments, the tang or tangs can be configured to engage the bodilytissue surrounding the implant 300 help retain the implant 300 in placewithin the body of the patient. The terms “tanged” or “tangs” as usedherein mean roughened or jagged edges or areas, such as can result fromcutting a woven or knit mesh material.

FIG. 4A illustrates a medical device 400 coupled to a syringe 480,according to an embodiment. The medical device 400 is configured to beused as an insertion tool or delivery tool to implant or insert a bodilyimplant (not shown) into a body of a patient (e.g., using an outside-inapproach via a vaginal incision in the body of the patient).

As shown in FIG. 4A, the medical device 400 has a receiving arm 410coupled (e.g., rotatably coupled, hingedly coupled) to a clamping arm420. The clamping arm 420 can be moved (e.g., rotatably moved) withrespect to the receiving arm 410 in a direction E1 and/or direction E2.The medical device 400 shown in FIG. 4A is in a clamped configuration,in some embodiments, the medical device 400 can also be moved to an openconfiguration. A sliding component 440 may be slidably moved along atrack 430 in direction F1 (towards a coupling mechanism 470) and/ordirection F2 (away from the coupling mechanism 470). The slidingcomponent 440 is shown in a deployed configuration in FIG. 4A, and, insome embodiments, the sliding component 440 may also be moved to astowed configuration. The sliding component 440 is coupled to (orincludes) a needle 460 that is configured to slidably move within alumen 452 of the guide 450.

In the embodiment shown in FIG. 4A the needle 460 of the medical device400 is configured to convey a fluid. The needle 460 can define a lumenthat is configured to convey fluids to and/or from a body of a patient.As shown in FIG. 4A, the sliding component 440 has a proximal portion442 that is coupled to the syringe 480. The syringe 480 is configured todeliver a fluid to and/or draw a fluid from the needle 460. In someembodiments, the syringe 480 is a 40 cc syringe. In other embodiments,the syringe 480 is larger or smaller than 40 cc. In some embodiments, adevice other than a syringe may be used to move a liquid through theneedle 460.

Although not shown in FIG. 4A, a tube, tether, or other deviceconfigured to convey a fluid can be disposed between the slidingcomponent 440 and the syringe 480. In other words, the syringe 480 canbe configured to deliver a fluid via a tube to the sliding component440. In such embodiments, the sliding mechanism 440 can be operated by afirst person (e.g., a first physician) and the syringe 480 can beoperated by a second person (e.g., a second physician).

In some embodiments, the syringe 480 may be coupled to the slidingcomponent 440 in a relatively rigid fashion so that the syringe 480 maybe used by a physician to move the sliding component 440. In otherwords, the medical device 400 may be configured so that a physician canslidably move the sliding component 440 along the track 430 by applyinga force (e.g., a pulling force, a pushing force) to the syringe 480. Insome embodiments, the medical device 400 may be configured so that aphysician can push and/or pull a plunger 482 of the syringe 480 (whilemoving the sliding component 440) to deliver and/or withdraw,respectively, a fluid from the lumen of the needle 460. Thus, a fluidmay be delivered and/or withdrawn via the needle 460 while the slidingcomponent 440 is in, or moving to, the stowed configuration and/or isin, or moving to, the deployed configuration. In some embodiments, thefluid may be delivered and/or withdrawn via the needle 460 while themedical device 400 is in, or moving to, the clamped configuration and/oris in, or moving to, the open configuration.

In some embodiments, for example, a lumen defined by the needle 460 maybe used to deliver medication or anesthesia to the body of the patientduring the procedure to place an implant within the body of the patient.In some embodiments, the lumen may be used to help hydro-dissect thebodily tissue during an implantation procedure. The lumen defined by theneedle 460 may be of any shape or size. For example, the cross-sectionalshape (or outer profile) of the lumen may be circular, square, orrectangular.

As shown in FIG. 4A, the medical device 400 has a locking mechanism 490configured to lockably couple the clamping arm 420 with respect to thereceiving arm 410. In other words, locking mechanism 490 can be used toreleasably lock the medical device 400 in one or more openconfigurations and/or one or more clamped configurations. Although notshown in FIG. 4A, the locking mechanism 490 can have one or moreprotrusions (e.g., teeth, latches) (not shown) that can be used to becoupled to (e.g., contact, catch on) one or more protrusions (e.g.,teeth, gear teeth) (not shown) disposed within the clamping arm 420. Theprotrusions, when coupled to the protrusion(s), can releasably lock aposition of the receiving arm 410 with respect to a position of theclamping arm 420.

As shown in FIG. 4A, at least a first portion of the locking mechanism490 is disposed within the receiving arm 410 and at least a secondportion of locking mechanism 490 is disposed within the clamping arm420. In some embodiments, at least a portion of locking mechanism 490may not be disposed inside of the receiving arm 410 and/or the clampingarm 420.

As shown in FIG. 4A, the locking mechanism 490 has a control lever 492(when pushed and/or pulled by a physician) that can be used to triggerthe locking mechanism 490 to releasably lock the medical device 400 inone or more open configurations and/or one or more clampedconfigurations. The control lever 492 (when pushed and/or pulled by aphysician) can also be configured to release the medical device 400 fromone or more releasably locked configurations.

Although not shown in FIG. 4A, in some embodiments, movement of thereceiving arm 410 can be limited with respect to the clamping arm 420.For example, movement of the receiving arm 410 can be limited so thatthe receiving arm 410, or a portion thereof (e.g., the couplingmechanism 470), may not come in contact with the clamping arm 420. Insome embodiments, the movement of the receiving arm 410 can be limitedwith respect to the clamping arm 420 by the locking mechanism 490 and/ora stop (not shown) disposed between the receiving arm 410 and theclamping arm 420.

FIG. 4B schematically illustrates the medical device 400 shown in FIG.4A in use with a body of a patient. As shown in FIG. 4B, at least aportion of the receiving arm 410 of the medical device 400 is disposedwithin a vaginal region 20 of a body of a patient. Also as shown in FIG.4B, the guide 450 of the clamping arm 420 is in relatively closeproximity to an obturator foramens 30 of the patient. The slidingcomponent 440 is in a deployed configuration so that at least a portionof the needle 460 pierces a tissue of the patient and is disposed withinthe body of the patient.

FIG. 5 illustrates another medical device 500, according to anembodiment. The medical device 500 is configured to be used as aninsertion tool or delivery tool to implant or insert a bodily implant(not shown) into a body of a patient (e.g., using an outside-in approachvia a vaginal incision in the body of the patient).

As shown in FIG. 5, the medical device 500 has a receiving arm 510coupled (e.g., hingedly coupled, rotatably coupled) to a clamping arm520. The clamping arm 520 can be moved (e.g., rotatably moved) withrespect to the receiving arm 510 in a direction K1 and/or a directionK2. The medical device 500 shown in FIG. 5 is in a clampedconfiguration, in some embodiments, the medical device 500 can also bemoved to an open configuration. In this embodiment, the receiving arm510 of the medical device 500 has a medial portion hingedly coupled to amedial portion of the clamping arm 520 of the medical device 500.

As shown in FIG. 5, a sliding component 540 may be slidably moved alonga track 530 in direction L1 (towards a coupling mechanism 570) and/ordirection L2 (away from the coupling mechanism 570). As shown in FIG. 5,the track 530 has a groove 532 along which sliding component 540slidably moves. Although not shown in FIG. 5, in some embodiments, thesliding component has a protrusion configured to slidably move withinthe groove 532. Also, as shown in FIG. 5, the sliding component 540includes a tab 548 (also can be referred to as a protrusion) that can beused to push and/or pull the sliding component 540.

The sliding component 540 is shown in a deployed configuration in FIG.5. In some embodiments, the sliding component 540 may also be moved to astowed configuration (where a distal portion 562 of the needle 560 isdisposed within a lumen 552 of a guide 550). The sliding component 540is coupled to (or includes) a needle 560 that is configured to slidablymove within the lumen 552 of the guide 550.

In the embodiment shown in FIG. 5 the needle 560 of the medical device500 is configured to convey a fluid. The needle 560 can define a lumenthat is configured to convey fluids to and/or from a body of a patient.As shown in FIG. 5, the sliding component 540 is coupled to a syringe580. The syringe 580 is configured to deliver a fluid to and/or draw afluid from the needle 560.

As shown in FIG. 5, the medical device 500 has a locking mechanism 590configured to lockably couple the clamping arm 520 with respect to thereceiving arm 510. In this embodiment, the locking mechanism 590 can bereferred to as a ratchet mechanism. The locking mechanism 590 can beused to releasably lock the medical device 500 in one or more openconfigurations and/or one or more clamped configurations.

The locking mechanism 590 has protrusions 594 (e.g., teeth) that can beconfigured to be coupled to (e.g., contact, catch on) protrusions 596(not shown in FIG. 5) (e.g., teeth) disposed within the clamping arm 520(and facing the protrusions 594). The protrusions 594, when coupled to(e.g., contacted with) the protrusions 596, can lock a position of thereceiving arm 510 with respect to a position of the clamping arm 520.The coupling of one or more of protrusions 594 to one or more of theprotrusions 596 can be released using lever 592.

In some embodiments, the locking mechanism 590 can be biased so that theposition of the receiving arm 510 is lockably coupled (e.g.,automatically lockably coupled) with respect to a position of theclamping arm 520 using the locking mechanism when the receiving arm 510is moved with respect to the clamping arm 520. In other words, theprotrusions 594 and the protrusions 596 can be biased (e.g., biasedusing a spring) to contact one another as the clamping arm 520 and thereceiving arm 510 are moved with respect to one another. In suchembodiments, lockable coupling of the position of the receiving arm 510with respect to the position of the clamping arm 520 can be releasedusing the lever 592. In some embodiments, the locking mechanism 590 canbe biased so that the position of the receiving arm 510 is lockablycoupled with respect to a position of the clamping arm 520 in responseto the lever being actuated. In other words, the locking mechanism 590can be biased to an unlocked configuration. In such embodiments, theprotrusions 594 and the protrusions 596 may not be biased (e.g., biasedusing a spring) away from one another and may not come into contactuntil activated using the lever 592.

As shown in FIG. 5, the locking mechanism 590 is defined by at least aportion (i.e., a proximal portion 512) of the receiving arm 510, whichis disposed within at least a portion (i.e., a proximal portion 522) ofthe clamping arm 520. In some embodiments, at least a portion of lockingmechanism 590 may not be disposed inside of the receiving arm 510 and/orthe clamping arm 520. In this embodiment, at least a portion of theproximal portion 512 of the receiving arm 510 and at least a portion ofthe proximal portion 522 of the clamping arm 520 collectively define ahandle portion of the medical device 500.

As shown in FIG. 5, the proximal portion 522 of the clamping arm 520 hasa window 598 through which indicators 511 (e.g., numbers, marks,detents) included in the proximal portion 512 of the receiving arm 510may be seen. The indicators 511 and the window 598 can be configured sothat one or more of the indicators 511 visible through the window 598can be an indicator of, for example, a distance between at least aportion of the receiving arm 510 (e.g., the coupling mechanism 570) andat least a portion of the clamping arm 520 (e.g., the track 530, adistal portion of the guide 550). In some embodiments, one or more ofthe indicators 511 can be an indicator of a relative positions (when themedical device 500 is in an open configuration and/or a clampedconfiguration) of at least a portion of the receiving arm 510 and atleast a portion of the clamping arm 520.

As shown in FIG. 5, the sliding mechanism 540 has a window 546 throughwhich indicators 531 (e.g., numbers, marks, detents) associated with(e.g., along) the track 530 may be seen. In some embodiments, the window546 and the indicators 531 can collectively define an indicatormechanism. The indicators 531 and the window 546 can be configured sothat one or more of the indicators 531 visible through the window 546can be an indicator of, for example, a distance between at least aportion of the sliding component 540 and/or needle 560 (e.g., the distalportion 562 of the needle 560) and at least a portion of the receivingarm 510 (e.g., the coupling mechanism 570). In other words, one or moreof the indicators 531 can be an indicator of a relative position (whenin a stowed configuration and/or a deployed configuration) between atleast a portion of the sliding component 540 and/or needle 560 (e.g.,the distal portion 562 of the needle 560) and at least a portion of thereceiving arm 510 (e.g., the coupling mechanism 570).

In some embodiments, the indicators 531 associated with (e.g., along)the track 530 can be correlated with the indicators 511 included on theproximal portion 512 of the receiving arm 510 so that one or more of theindicators 531 can be used to determine when at least a portion of thedistal portion 562 of the needle 560 is disposed within the couplingmechanism 570 and/or has contacted a portion of an implant coupled withthe coupling mechanism 570. For example, when the receiving arm 510 canbe moved within respect to a position of the clamping arm 520 in aclamped configuration of medical device 500 until an indicator from theindicators 511 is visible through the window 598. The medical device 500can be configured so that at least a portion (e.g., a distal tip) of thedistal portion 562 of the needle 560 will be disposed within thecoupling mechanism 570 when the sliding component 540 is moved until anindicator from the indicators 531 that is visible through the window 546matches the indicator from the indicators 511. In some embodiments, thewindow 598 and the indicators 511 can collectively define an indicatormechanism.

In some embodiments, medical device 500 can include one or moreelectronic indicators (e.g., light emitting diode (LED) indicatorscoupled to electronic contacts and a power supply, liquid crystaldisplay indicators triggered by a microprocessor). For example, themedical device 500 can include an electronic indicator configured toindicate a position of at least a portion of the receiving arm 510(e.g., the coupling mechanism 570) with respect to at least a portion ofthe clamping arm 520 (e.g., the track 530, a distal portion of the guide550). In some embodiments, the medical device 500 can include anelectronic indicator configured to indicate a relative position betweenat least a portion of the sliding component 540 and/or needle 560 (e.g.,the distal portion 562 of the needle 560) and at least a portion of thereceiving arm 510 (e.g., the coupling mechanism 570).

FIG. 6 illustrates yet another medical device 600 according to anembodiment. The medical device 600 is configured to be used as aninsertion tool or delivery tool to implant or insert a bodily implant(not shown) into a body of a patient. As shown in FIG. 6, the medicaldevice 600 has a receiving arm 610 coupled (e.g., hingedly coupled) to aclamping arm 620. The clamping arm 620 can be moved (e.g., rotatablymoved) with respect to the receiving arm 610 in a direction G1 and/or adirection G2. The medical device 600 shown in FIG. 6 is in a clampedconfiguration, in some embodiments, the medical device 600 can also bemoved to an open configuration. In this embodiment, the receiving arm610 of the medical device 600 has a proximal portion 612 hingedlycoupled to a proximal portion 622 of the clamping arm 620 of the medicaldevice 600.

As shown in FIG. 6, a sliding component 640 may be slidably moved alonga track 630 in direction H1 (towards a coupling mechanism 670) and/ordirection H2 (away from the coupling mechanism 670). In this embodiment,the coupling mechanism 670 defines a cavity 672. As shown in FIG. 6, thetrack 630 has a groove 632 along which sliding component 640 slidablymoves.

The sliding component 640 is shown in a stowed configuration in FIG. 6(where a distal portion 662 of a needle 660 is disposed within a lumen652 of a guide 650). In some embodiments, the sliding component 640 mayalso be moved to a deployed configuration (not shown). The needle 660 iscoupled to the sliding component 640 and is configured to slidably movewithin the lumen 652 of the guide 650.

As shown in FIG. 6, the sliding component 640 includes a lockingmechanism 647 configured to releasably lock the sliding component 640 ina position along the track 630. In some embodiments, the slidingcomponent 640 can be releasably locked in any position along the track630 using a lever 649 (e.g., a protrusion, a tab). For example, thesliding component 640 can be releasably locked in the stowedconfiguration shown in FIG. 6.

In some embodiments, the locking mechanism 647 can be biased so that thesliding component 640 may not be moved along the track 630 unless thelever 649 is actuated. In other words, the locking mechanism 647 can beconfigured so that the lever 649 can be actuated to release the lockingmechanism so that the sliding component 640 may be slidably moved alongthe track 630. In some embodiments, the locking mechanism 647 can bebiased so that the sliding component 640 may not be locked into aposition along the track 630 until actuated using the lever 649. Inother words, the locking mechanism 647 can be configured so that thelever 649 can be actuated to lock the sliding component 640 along thetrack 630.

In the embodiment shown in FIG. 6 the needle 660 of the medical device600 is configured to convey a fluid. The needle 660 can define a lumenthat is configured to convey fluids to and/or from a body of a patient.As shown in FIG. 6, the sliding component 640 is coupled at 642 to asyringe 680 that has a plunger 682. The syringe 680 is configured todeliver a fluid to and/or draw a fluid from the needle 660.

As shown in FIG. 6, the medical device 600 has a locking mechanism 690configured to lockably couple the clamping arm 620 with respect to thereceiving arm 610. In this embodiment, the locking mechanism 690 can bereferred to as a ratchet mechanism. The locking mechanism 690 can beused to releasably lock the medical device 600 in one or more openconfigurations and/or one or more clamped configurations. As shown inFIG. 6, the sliding component 640 includes a tab 648 (also can bereferred to as a protrusion) that can be used to push and/or pull thesliding component 640.

The locking mechanism 690 has protrusions 694 (e.g., teeth) that can beconfigured to be coupled to (e.g., contact, catch on) a protrusion 696disposed within the clamping arm 620 (and facing the protrusions 694).The protrusions 694, when coupled to (e.g., contacted with) theprotrusion 696, can lock a position of the receiving arm 610 withrespect to a position of the clamping arm 620. The coupling of one ormore of the protrusions 694 to the protrusion 696 can be released usinga rotatable lever 692. In some embodiments, the locking mechanism 690can be biased (via the rotatable lever 692) towards a lockedconfiguration (e.g., being lockably coupled), or biased to an unlockedconfiguration.

As shown in FIG. 6, the medical device 600 includes an indicator member697 (coupled to the locking mechanism 690) configured to align with oneor more of the indicators 631 associated with (aligned along) the track630. In some embodiments, the indicator member 697 and the indicators631 can collectively define an indicator mechanism. In some embodiments,the indicator member 697, when aligned with one or more of theindicators 631, can indicate, for example, a distance between at least aportion of the receiving arm 610 (e.g., the coupling mechanism 670) andat least a portion of the clamping arm 620 (e.g., the track 630, adistal portion of the guide 650). In other words, one or more of theindicators 631 (when pointed to by the indicator member 697) can be anindicator of a relative positions (when the medical device 600 is in anopen configuration and/or a clamped configuration) of at least a portionof the receiving arm 610 and at least a portion of the clamping arm 620.

In some embodiments, the indicator member 697 can also be configured tolimit movement of the sliding component 640. For example, as shown inFIG. 6, the indicator member 697 can be configured to prevent (e.g.,configured to prevent as a safety stop) the sliding component 640 frommovement to a position beyond the indicator member 697. The slidingcomponent 640 can have a protrusion (e.g., a tab) (not shown) thatlimits (e.g., stops) the movement of the sliding component 640 when theprotrusion comes into contact with the indicator member 697. In someembodiments, the indicator member 697 may not function as a safety stop.In some embodiments, the medical device 600 (e.g., the sliding component640, the track 630) can have a safety stop that does not function as anindicator. In some embodiments, a safety stop can be configured to limitthe movement of the sliding component 640 so that the needle 660 may notbe moved into a body of a patient in an undesirable fashion (e.g.,beyond a specified point within the body of the patient).

In some embodiments, the indicator member 697, when aligned with one ormore of the indicators 631, can indicate, for example, a target positionof the sliding component 640 along the track 630. The target positioncan be a position at which at least a portion of the needle 660 is, forexample, moved into or near the cavity 672 of the coupling mechanism 670so that the needle 660 is coupled to at least a portion of an implantcoupled to the coupling mechanism 670. In some embodiments, the targetposition can be a position at which at least a portion of the needle 660comes into contact with at least a portion of an implant coupled to thecoupling mechanism 670.

In some embodiments, the indicator member 697 can be configured so thatthe distal portion 662 of the needle 660 will precisely move into thecavity 672 of the coupling mechanism 670 of the receiving arm 610. Forexample, the receiving arm 610 can be moved towards the clamping arm 620so that a distal end (a front portion) of the guide 650 is a distancefrom the coupling mechanism 670. The indicator member 697 can beconfigured to limit the movement of the sliding component so that theportion of the needle 660 that is extended from (deployed from) thedistal end of the guide 650 has a length that is approximately equal to,slightly greater than, or equal to the distance.

In some embodiments, as schematically illustrated in FIG. 7A, an implant(such as the implant 300 shown in FIG. 3) can be positioned, at least inpart, by the medical devices described herein between a portion of avagina V of a patient and a portion of a bladder BL of the patient suchthat the implant provides support to the bladder BL of the patient.

As illustrated in FIG. 7B, an implant (such as the implant 300 shown inFIG. 3) may be positioned, at least in part, by the medical devicesdescribed herein at different locations within the body of the patient.For example, as illustrated in FIG. 7B, implant A may be placed withinthe body of the patient such that the implant A extends through theobturator foramens OF of the patient. Alternatively, as illustrated, theimplant B may extend between the midline incision, Ischiocavernosusmuscle IC and in front of the pubic bone (prepubic approach).Alternatively, as illustrated, implant C may be disposed within the bodyof the patient in a “V” shape. Although not shown, in some embodiments,the implant B may extend between the ATFP (arcus tendineus facia pelvis)and the obturators of the patient.

As illustrated in FIG. 7C, an implant (such as the implant 300 shown inFIG. 3) may be placed, at least in part, by the medical devicesdescribed herein such that it extends toward the obturator foramens OFof the patient, but does not extend through the obturator foramens OF.For example, the implant may be disposed within or coupled to musclesdisposed proximate the obturator foramens OF. In some embodiments, theimplant may be decoupled from an end of a needle (after being retrievedfrom a coupling mechanism) of the medical device after being placedwithin a desirable location within the body of the patient using adecoupling mechanism (e.g., a latch mechanism, a decoupling mechanism atan end of the needle member) controlled using, for example, a lever,trigger, and/or so forth. In some embodiments, the medical devicesdescribed herein may be used to deliver an implant to the pelvic regionof the patient via a retropubic (below) or a suprapubic (above)approach.

FIG. 8 is a flow diagram that illustrates a method for using a medicaldevice. In some embodiments, the medical device can be similar to, orthe same as, the medical devices (e.g., medical device 100 shown in FIG.1, medical device 200 shown in FIG. 2A) described above.

At least a portion of an implant is inserted into a receiving arm of amedical device (block 800). In some embodiments, the portion of theimplant can be, for example, a tether or suture of the implant. In someembodiments, the portion of the implant can be inserted into a couplingmechanism of a receiving arm.

At least a portion of the receiving arm is inserted into a body of apatient (block 810). In some embodiments, the receiving arm can beinserted into a vaginal region of a body of a patient or a rectal regionof a body of a patient. The receiving arm can be inserted after theportion of the implant is coupled to the coupling mechanism.

A clamping arm rotatably coupled to the receiving arm moved toward thereceiving arm (block 820). In some embodiments, the clamping arm can behingedly coupled to the receiving arm of the medical device. Theclamping arm can be moved towards the receiving arm until a guide of theclamping arm is compressed against a skin tissue of the patient. In someembodiments, the clamping arm can be releasably locked in a positionwith respect to the receiving arm. In some embodiments, a lockingmechanism can be released (can be moved to an unlocked configuration)before the clamping arm is moved towards the receiving arm.

A sliding component coupled to the clamping arm is moved in a firstdirection along a track of the clamping arm toward the receiving armsuch that a needle of the sliding component is moved into the body ofthe patient and is coupled to the portion of the implant (block 830).The sliding component can be moved after a locking mechanism has beenreleased (is moved to an unlocked configuration). In some embodiments,the sliding component can be biased away from the receiving arm so thata force must be applied to the sliding component to move the slidingcomponent towards the receiving arm. The needle can have a couplingcomponent configured to be coupled to the portion of the implant. Insome embodiments, the sliding component can be biased toward thereceiving arm so that the sliding component moves toward the receivingarm in response to a locking mechanism being released.

The sliding component coupled to the clamping arm moved in a seconddirection along the track of the clamping arm away from the receivingarm until the portion of the implant coupled to the needle of thesliding component is moved outside of the body of the patient (block840). In some embodiments, the clamping arm can be biased (e.g., biasedwith a spring mechanism) away from the receiving arm so that theclamping arm automatically moves away from the receiving arm and pullsthe portion of the implant (and the needle) out of the body of thepatient.

FIG. 9 illustrates yet another medical device 900, according to anembodiment. The medical device 900 is configured to be used as aninsertion tool or delivery tool to implant or insert a bodily implant(not shown) into a body of a patient (e.g., using an outside-in approachvia a vaginal incision in the body of the patient).

As shown in FIG. 9, the medical device 900 has a receiving arm 910coupled to a clamping arm 920. The clamping arm 920 can be moved (e.g.,slidably moved) with respect to the receiving arm 910 in a direction J1and/or a direction J2 along a track 935 of the receiving arm 910. Thetrack 935 can be similar to the tracks described above. The medicaldevice 900 shown in FIG. 9 is in an open configuration, in someembodiments, the medical device 900 can also be moved to a clampedconfiguration.

Although the track 935 is shown as being included in (or associatedwith) the receiving arm 910, in some embodiments, the track 935 can beincluded in (or associated with) the clamping arm 920. In someembodiments, the track 935 can be a separate component (e.g., a trackcomponent) along which both the receiving arm 910 and the clamping arm920 can be slidably moved. In such embodiments, the receiving arm 910and the clamping arm 920 can be independently slidably moved along thetrack 935.

Also, as shown in FIG. 9, a sliding component 940 may be slidably movedalong a track 930 (e.g., a track associated with the sliding component940) in the direction J1 (towards a coupling mechanism 970) and/or thedirection J2 (away from the coupling mechanism 970). The slidingcomponent 940 is shown in a stowed configuration in FIG. 9 (where adistal portion 962 of the needle 960 is disposed within a lumen 952 of aguide 950). In some embodiments, the sliding component 940 may also bemoved to a deployed configuration. The sliding component 940 is coupledto (or includes) a needle 960 that is configured to slidably move withinthe lumen 952 of the guide 950. Although shown as a straight track 930and a straight needle 960 in FIG. 9, in some embodiments, the track 930and the needle 960 can be curved.

Medical device 900 shown in FIG. 9 can include any of the featuresdescribed in connection with and/or shown in the medical devices above.For example, medical device 900 can include one or more lockingmechanisms, indicator mechanisms, ratchet mechanisms, syringes, and/orso forth.

In some embodiments, the sliding component 940 can be slidably movedalong the track 930 using a device configured to apply a force to thesliding component 940. For example, sliding component 940 can be movedalong direction J1 and/or direction J2 using a motor. In someembodiments, the motor can be installed inside of the sliding component940 and can be actuated by physician using a button coupled to themedical device. In some embodiments, the sliding component 940 can beslidably moved along the track 930 using, for example, a ball-screwmechanism (not shown) coupled to a motor. Similarly, the clamping arm920 and the receiving arm 910 can be moved toward one another using adevice configured to apply a force to the clamping arm 920 and/or thereceiving arm 910. One or more of the medical devices described abovecan incorporate a device (e.g., a motor) configured to slidably move asliding mechanism and/or rotatably move portions of the medical devices.

FIG. 10 illustrates yet another medical device 1000 according to anembodiment. Some portions of FIG. 10 are shown in “see-through” so thatat least some internal components may be viewed. In some embodiments,some portions of the medical device 1000, when implemented, may betranslucent and some portions of the medical device 1000, whenimplemented, may not be translucent. The medical device 1000 isconfigured to be used as an insertion tool or delivery tool to implantor insert a bodily implant (not shown) into a body of a patient. Asshown in FIG. 10, the medical device 1000 has a receiving arm 1010coupled (e.g., hingedly coupled) to a clamping arm 1020. The clampingarm 1020 can be moved (e.g., rotatably moved) with respect to thereceiving arm 1010 in a direction Ml and/or a direction M2. The medicaldevice 1000 shown in FIG. 10 is in a clamped configuration, in someembodiments, the medical device 1000 can also be moved to an openconfiguration. In this embodiment, the receiving arm 1010 of the medicaldevice 1000 has a proximal portion 1012 hingedly coupled to a proximalportion 1022 of the clamping arm 1020 of the medical device 1000.

As shown in FIG. 10, a sliding component 1040 may be slidably movedalong a track 1030 in direction N1 (towards a coupling mechanism 1070)and/or direction N2 (away from the coupling mechanism 1070). In thisembodiment, the coupling mechanism 1070 defines a cavity 1072. As shownin FIG. 10, the track 1030 has a groove 1032 along which slidingcomponent 1040 slidably moves.

The sliding component 1040 is shown in a deployed configuration in FIG.10 (where a distal portion 1062 of a needle 1060 is disposed outside ofa lumen 1052 of a guide 1050). In some embodiments, the slidingcomponent 1040 may also be moved to a stowed configuration (not shown).The needle 1060 is coupled to the sliding component 1040 and isconfigured to slidably move within the lumen 1052 of the guide 1050.Although not shown in FIG. 10, the sliding component 1040 can include alocking mechanism configured to releasably lock the sliding component1040 in a position along the track 1030.

As shown in FIG. 10, the receiving arm 1010 has a trigger handle 1015such that the receiving arm 1010 defines approximately a V-shape. Inthis embodiment, at least a portion of the trigger handle 1015 of thereceiving arm 1010 is disposed within the clamping arm 1020. The triggerhandle 1015 also includes an opening 1017 into which a finger of aphysician may be inserted. In some embodiments, the trigger handle 1015may not have a portion disposed within the clamping arm 1020. Theclamping arm 1020 can be moved towards, or over, at least a portion ofthe trigger handle 1015 of the receiving arm 1010 such that the track1030 and guide 1050 of the clamping arm 1020 are moved towards thecoupling mechanism 1070. For example, a physician can grasp the triggerhandle 1015 with one or more fingers so that a heel or palm of thephysician's hand (or another portion of the physician's hand) is againstthe clamping arm 1020. The physician can squeeze the medical device 1000so that the clamping arm 1020 is moved towards, or over, at least aportion of the trigger handle 1015 of the receiving arm 1010. In someembodiments, the medical device 1000 may be squeezed more than onceduring a medical procedure until the clamping arm 1020 is moved to adesirable position with respect to the receiving arm 1010, or a portionthereof (e.g., the coupling mechanism 1070 of the receiving arm 1010).In some embodiments, the clamping arm 1020 may be moved along directionMl more than once and/or along direction M2 more than once so that theclamping arm 1020 may be moved to a desirable position with respect tothe receiving arm 1010, or a portion thereof, during a medicalprocedure.

As shown in FIG. 10, the medical device 1000 has a locking mechanism1090 configured to lockably couple the clamping arm 1020 with respect tothe receiving arm 1010. In this embodiment, the locking mechanism 1090can be referred to as a ratchet mechanism. The locking mechanism 1090can be used to releasably lock the medical device 1000 in one or moreopen configurations and/or one or more clamped configurations. In thisembodiment, the locking mechanism 1090 can be configured to releasablylock the clamping arm 1020 with respect to the receiving arm 1010 as theclamping arm 1020 is moved towards, or over, at least a portion of thetrigger handle 1015 of the receiving arm 1010. For example, the lockingmechanism 1090 can be configured to releasably lock the clamping arm1020 with respect to the receiving arm 1010 as a physician squeezes themedical device 1000 so that the clamping arm 120 is moved towards, orover, at least a portion of the trigger handle 1015 of the receiving arm1010.

In some embodiments, a physician may squeeze the medical device 1000during a first time period (starting at a first time) so that theclamping arm 1020 is lockably coupled using the locking mechanism 1090in a first position with respect to the receiving arm 1010 (e.g., thecoupling mechanism 1070 of the receiving arm 1010). In some embodiments,the physician may squeeze the medical device 1000 during a second timeperiod (after the first time period and starting at a second time) sothat the clamping arm 1020 is lockably coupled using the lockingmechanism 1090 in a second position with respect to the receiving arm1010 (e.g., the coupling mechanism 1070 of the receiving arm 1010). Insome embodiments, the clamping arm 1020 may be closer to the receivingarm 1010 when the clamping arm 1020 is in the first position withrespect to the receiving arm 1010 (or a portion thereof) than when theclamping arm 1020 is in the second position with respect to thereceiving arm 1010 (or a portion thereof). In some embodiments, thelocking mechanism 1090 may be released (e.g., released by the physician)one or more times by the physician between the first time period and thesecond time period. In such embodiments, the clamping arm 1020 may bemoved away from the receiving arm 1010 (or a portion thereof) alongdirection M2 after the locking mechanism 1090 has been released. In suchembodiments, the clamping arm 1020 may be farther from the receiving arm1010 when the clamping arm 1020 is in the first position with respect tothe receiving arm 1010 (or a portion thereof) than when the clamping arm1020 is in the second position with respect to the receiving arm 1010(or a portion thereof).

In the illustrated embodiment, the locking mechanism 1090 hasprotrusions 1094 (e.g., teeth) that can be configured to be coupled to(e.g., contact, catch on) a protrusion 1096 disposed within the clampingarm 1020 (and facing the protrusions 1094) and included in rotatablemechanism 1095. The protrusions 1094, when coupled to (e.g., contactedwith) the protrusion 1096, can lock a position of the receiving arm 1010with respect to a position of the clamping arm 1020. The coupling of oneor more of the protrusions 1094 to the protrusion 1096 can be releasedusing a rotatable lever 1092, which is configured to contact and pushagainst a lever of rotatable mechanism 1095. In some embodiments, thelocking mechanism 1090 can be biased (via the rotatable lever 1092)towards a locked configuration (e.g., being lockably coupled), or biasedto an unlocked configuration.

In this embodiment, the proximal portion 1022 of the clamping arm 1020and the proximal portion 1012 of the receiving arm 1010 collectivelydefine a finger hole 1013. Also, in this embodiment, the proximalportion 1022 of the clamping arm 1020 and the proximal portion 1012 ofthe receiving arm 1010 are hingedly coupled at the finger hole 1013. Thefinger hole 1013 can be used by, for example, a physician to grasp themedical device 1000. In some embodiments, the finger hole 1013 can bedefined by only the proximal portion 1022 of the clamping arm 1020 orthe proximal portion 1012 of the receiving arm 1010. In someembodiments, the proximal portion 1022 of the clamping arm 1020 and theproximal portion 1012 of the receiving arm 1010 are not hingedly coupledat the finger hole 1013.

As shown in FIG. 10, the medical device 1000 includes an indicatormember 1097, which is part of (e.g., integrated as part of) the triggerhandle 1015. The indicator member 1097 is configured to align with oneor more of the indicators 1031 (e.g., numbers, marks, detents)associated with (aligned along) the track 1030. In some embodiments, theindicator member 1097 and the indicators 1031 can collectively define anindicator mechanism. In some embodiments, the indicator member 1097,when aligned with one or more of the indicators 1031, can indicate, forexample, a distance between at least a portion of the receiving arm 1010(e.g., the coupling mechanism 1070) and at least a portion of theclamping arm 1020 (e.g., the track 1030, a distal portion of the guide1050). In other words, one or more of the indicators 1031 (when pointedto by the indicator member 1097) can be an indicator of a relativepositions (when the medical device 1000 is in an open configurationand/or a clamped configuration) of at least a portion of the receivingarm 1010 and at least a portion of the clamping arm 1020. In someembodiments, at least a portion of the track 1030 may be translucent(for example, formed of a translucent material) so that the indicatormember 1097 may be visible to a physician using the medical device 1000.

In some embodiments, the indicator member 1097 can also be configured tolimit movement of the sliding component 1040. For example, as shown inFIG. 10, the indicator member 1097 can be configured to prevent thesliding component 1040 from movement to a position beyond the indicatormember 1097. The sliding component 1040 can have a protrusion (e.g., atab) (not shown) that limits (e.g., stops) the movement of the slidingcomponent 1040 when the protrusion comes into contact with the indicatormember 1097.

In some embodiments, the indicator member 1097, when aligned with one ormore of the indicators 1031, can indicate, for example, a targetposition of the sliding component 1040 along the track 1030. The targetposition can be a position at which at least a portion of the needle1060 is, for example, moved into or near the cavity 1072 of the couplingmechanism 1070 so that the needle 1060 is coupled to at least a portionof an implant coupled to the coupling mechanism 1070. In someembodiments, the target position can be a position at which at least aportion of the needle 1060 comes into contact with at least a portion ofan implant coupled to the coupling mechanism 1070.

In some embodiments, the indicator member 1097 can be configured so thata distal portion of the needle 1060 will precisely move into the cavity1072 of the coupling mechanism 1070 of the receiving arm 1010. Forexample, the receiving arm 1010 can be moved towards the clamping arm1020 so that a distal end (a front portion) of the guide 1050 is adistance from the coupling mechanism 1070. The indicator member 1097 canbe configured to limit the movement of the sliding component so that theportion of the needle 1060 that is extended from (deployed from) thedistal end of the guide 1050 has a length that is approximately equalto, slightly greater than, or equal to the distance.

As shown in FIG. 10, the sliding component 1040 includes a lockingmechanism 1049 configured to releasably lock the sliding component 1040in a position along the track 1030. In some embodiments, the slidingcomponent 1040 can be releasably locked in any position along the track1030 using the locking mechanism 1049 (e.g., a protrusion, a tab). Forexample, the sliding component 1040 can be releasably locked in thedeployed configuration shown in FIG. 10.

In some embodiments, the locking mechanism 1049 can be biased so thatthe sliding component 1040 may not be moved along the track 1030 unlessthe locking mechanism 1049 is actuated. In other words, the lockingmechanism 1049 can be configured so that the locking mechanism 1049 canbe actuated to release the locking mechanism so that the slidingcomponent 1040 may be slidably moved along the track 1030. In someembodiments, the locking mechanism 1049 can be biased so that thesliding component 1040 may not be locked into a position along the track1030 until actuated using the locking mechanism 1049. In other words,the locking mechanism 1049 can be configured so that the lockingmechanism 1049 can be actuated to lock the sliding component 1040 alongthe track 1030.

In the embodiment shown in FIG. 10 the needle 1060 of the medical device1000 is configured to convey a fluid. The needle 1060 can define a lumenthat is configured to convey fluids to and/or from a body of a patient.As shown in FIG. 10, the sliding component 1040 is coupled at 1042 to asyringe 1080 that has a plunger 1082. The syringe 1080 is configured todeliver a fluid to and/or draw a fluid from the needle 1060.

FIGS. 11A through 11I illustrate yet another medical device 1100according to an embodiment. Some portions of the figures (e.g., FIGS.11C and 11E) are shown in “see-through” so that at least some internalcomponents may be viewed. In some embodiments, some portions of themedical device 1100, when implemented, may be translucent and someportions of the medical device 1100, when implemented, may not betranslucent. The medical device 1100 is configured to be used as aninsertion tool or delivery tool to implant or insert a bodily implant(not shown) into a body of a patient. As shown in FIG. 11A, the medicaldevice 1100 has a receiving arm 1110 coupled (e.g., hingedly coupled) toa clamping arm 1120. The clamping arm 1120 can be moved (e.g., rotatablymoved) with respect to the receiving arm 1110 in a direction 01 and/or adirection 02. The medical device 1100 shown in FIG. 11A (and also shownin, for example, FIG. 11B) is in a clamped configuration, in someembodiments, the medical device 1100 can also be moved to an openconfiguration as shown in FIG. 11C and FIG. 11G.

In this embodiment, the receiving arm 1110 of the medical device 1100has a portion hingedly coupled at a hinge 1112 to a portion of theclamping arm 1120 of the medical device 1100. In this embodiment, theportion of the receiving arm 1110 of the medical device 1100 and theportion of the clamping arm 1120 of the medical device 1100 collectivelydefine a finger hole 1113. Thus, in this embodiment, the portion of theclamping arm 1120 and the portion of the receiving arm 1110 are hingedlycoupled at the finger hole 1113. The finger hole 1113 can be used by,for example, a physician to grasp the medical device 1100. Although notshown, in some embodiments, the finger hole 1113 can be defined by onlya portion of the clamping arm 1120 or only a portion of the receivingarm 1110. In some embodiments, the proximal portion 1122 of the clampingarm 1120 and the proximal portion 1112 of the receiving arm 1110 are nothingedly coupled at the finger hole 1113.

As shown in FIG. 11A, a sliding component 1140 may be slidably movedalong a track 1130 in direction P1 (towards a coupling mechanism 1170)and/or direction P2 (away from the coupling mechanism 1170). In thisembodiment, the coupling mechanism 1170 defines a cavity 1172. As shownin FIG. 11A, the track 1130 has a groove 1132 along which slidingcomponent 1140 slidably moves.

The sliding component 1140 is shown in a deployed configuration in FIG.11A (also shown at least in FIGS. 11D, 11E, 11H, and 11I) where a distalportion 1162 of a needle 1160 is disposed outside of a lumen of a guide1150. In this embodiment, the guide 1150 includes multiple sections anddefines multiple lumens. In some embodiments, the sliding component 1140may also be moved to a stowed configuration (shown at least in FIGS.11B, 11C, 11F, and 11G). The needle 1160 is coupled to the slidingcomponent 1140 and is configured to slidably move within the lumen ofthe guide 1150.

As shown in at least FIG. 11A, the medical device 1100 includes sideprotrusions 1192 (also can be referred to as tabs) coupled to at least aportion of the clamping arm 1120. One or more of the side protrusions1192 can be used by a physician to push (e.g., push using a thumb) theclamping arm 1120 toward the receiving arm 1110 (from an openconfiguration (such as that shown in FIG. 11C and FIG. 11G) to a clampedconfiguration (such as that shown in FIG. 11A)). In some embodiments,one or more of the side protrusions 1192 can be used to hold the medicaldevice 1100 in a clamped configuration after the medical device 1100 hasbeen moved to the clamped configuration using one or more of the sideprotrusions 1192. In some embodiments, one or more of the sideprotrusions 1192 can be used (e.g., using a pulling motion) to move themedical device 1100 from a clamped (or closed configuration) to an openconfiguration.

As shown in at least FIG. 11A, the side protrusions 1192 have a smoothportion 1193 (e.g., relatively smooth portion) and a rough portion 1194(e.g., a relatively rough portion). The smooth portion 1193 can beconfigured so that a portion (e.g., a thumb) of a hand of a physicianmay slide (e.g., slidably move) along the smooth portion 1193 as thesmooth portion 1193 of the side protrusion 1192 is used to move theclamping arm 1120 toward the receiving arm 1110. The rough portion 1194can be configured so that a portion (e.g., a thumb) of a hand of aphysician may be prevented from sliding (e.g., slidably moving) alongthe rough portion 1194 as the smooth portion 1194 of the side protrusion1192 is used to move the clamping arm 1120 toward the receiving arm1110.

In this embodiment, the rough portion 1192 is defined by a bumpysurface. In some embodiments, the smooth portion 1193 and/or the roughportion 1194 may be defined by various elements that are different thanthose shown in at least FIG. 11A. For example, the rough portion 1194can include, or can be made of, a rough adhesive substance such assandpaper, a sticky substance, circular bumps, and/or so forth. Althoughnot shown in FIG. 11A, in some embodiments, a single side protrusion1192 may have multiple smooth portions and/or multiple rough portions.

As shown in at least FIG. 11A, the medical device 1100 includes topprotrusions 1195 (also can be referred to as tabs) coupled to at least aportion of the clamping arm 1120. One or more of the top protrusions1195 can be used by a physician to push (e.g., push using a thumb) theclamping arm 1120 toward the receiving arm 1110 (from an openconfiguration (such as that shown in FIG. 11C and FIG. 11G) to a clampedconfiguration (such as that shown in FIG. 11A)). In some embodiments,one or more of the top protrusions 1195 can be used to hold the medicaldevice 1100 in a clamped configuration after the medical device 1100 hasbeen moved to the clamped configuration using one or more of the topprotrusions 1195. In some embodiments, one or more of the topprotrusions 1195 can be used (e.g., using a pulling motion) to move themedical device 1100 from a clamped (or closed configuration) to an openconfiguration.

In this embodiment, the top protrusions 1195 each have a rough portionthat is defined by a bumpy surface. In some embodiments, the surfaces ofthe rough portions of the top protrusions 1195 may be defined by variouselements that are different than those shown in at least FIG. 11A. Forexample, the top protrusions 1195 can have a surface that includes, orcan be made of, a rough adhesive substance such as sandpaper, a stickysubstance, circular bumps, and/or so forth. Although not shown in FIG.11A, in some embodiments, one or more of the top protrusions 1195 maynot have a have a rough portion.

In some embodiments, one or more of the side protrusions 1192 and/or oneor more of the top protrusions 1195 can be used by a physician tomaneuver the medical device 1100 when, for example, moving the receivingarm 1110 into a body of a patient. In some embodiments, the medicaldevice 1100 can have a single side protrusion rather than two sideprotrusions 1192 as shown in FIG. 11A, and/or can have a single topprotrusion rather than two top protrusions 1195 as shown in FIG. 11A. Insome embodiments, the medical device 1100 can have a more than two sideprotrusions, and/or can have a more than two top protrusions. In someembodiments, the shape of the side protrusions 1192 and/or the topprotrusions 1195 can be different than those shown in FIG. 11A. In someembodiments, the side protrusions 1192 and/or the top protrusions 1195can have a triangular profile, can have a square profile, may not have acurved profile, and/or so forth.

In some embodiments, the medical device 1100 may be biased (e.g., biasusing a spring mechanism) to an open configuration. Accordingly, one ormore of the side protrusions 1192 and/or one or more of the topprotrusions 1195 can be used to move the medical device 1100 from theopen configuration to a closed configuration by applying a force (e.g.,by a physician) to the side protrusion(s) 1192 and/or the topprotrusion(s) 1195. When the force is no longer applied to the sideprotrusion(s) 1192 and/or the top protrusion(s) 1195, the medical device1100 may move back to the open configuration in response to the biasing.

In some embodiments, a physician may move, using one or more of the sideprotrusions 1192 and/or one or more of the top protrusions 1195, themedical device 1100 during a first time period (starting at a firsttime) so that the clamping arm 1120 is moved to a first position withrespect to the receiving arm 1110 (e.g., the coupling mechanism 1170 ofthe receiving arm 1110). In some embodiments, the physician may move,using one or more of the side protrusions 1192 and/or one or more of thetop protrusions 1195, the medical device 1100 during a second timeperiod (after the first time period and starting at a second time) sothat the clamping arm 1120 is moved to a second position with respect tothe receiving arm 1110 (e.g., the coupling mechanism 1170 of thereceiving arm 1110). In some embodiments, the clamping arm 1120 may becloser to the receiving arm 1110 when the clamping arm 1120 is in thefirst position with respect to the receiving arm 1110 (or a portionthereof) than when the clamping arm 1120 is in the second position withrespect to the receiving arm 1110 (or a portion thereof). In someembodiments, a force applied by the physician against one or more of theside protrusions 1192 may be released (e.g., released by the physician)one or more times by the physician between the first time period and thesecond time period. In such embodiments, the clamping arm 1120 may bemoved away from the receiving arm 1110 (or a portion thereof) alongdirection 02 after being released. In such embodiments, the clamping arm1120 may be farther from the receiving arm 1110 when the clamping arm1120 is in the first position with respect to the receiving arm 1110 (ora portion thereof) than when the clamping arm 1120 is in the secondposition with respect to the receiving arm 1110 (or a portion thereof).

As shown in at least FIG. 11A, the medical device 1100 includes a handle1115. In some embodiments, the handle 1115 can be used by a physician tomaneuver the medical device 1100 when, for example, moving the receivingarm 1110 into a body of a patient. In this embodiment, at least aportion of the handle 1115 is coupled to a portion 1117 disposed withinthe clamping arm 1120 when the medical device 1100 is in theconfiguration shown in FIG. 11A.

The clamping arm 1120 can be moved over at least the portion 1117 of thereceiving arm 1110 as the track 1130 and guide 1150 of the clamping arm1120 are moved towards or away from the coupling mechanism 1170. Forexample, a physician can grasp the portion 1117 with one or more fingersso that a heel or palm of the physician's hand (or another portion ofthe physician's hand) is against the clamping arm 1120. The physiciancan squeeze the medical device 1100 while the medical device 1100 is inthe configuration shown in FIG. 11C (or FIG. 11G) so that the clampingarm 1120 is moved towards, or over, at least the portion 1117 of thereceiving arm 1110 toward the configuration shown in FIG. 11A (or FIG.11H or FIG. 11I) or the configuration shown in FIG. 11B (or FIG. 11F).While in the configuration shown in FIG. 11A, the portion 1117 issubstantially disposed within the clamping arm 1120. At least a firstportion of the portion 1117 is substantially disposed on one side of theclamping arm 1120 while in the configuration shown in FIG. 11B, and atleast a second portion of the portion 1117 is substantially disposed onanother side of the clamping arm 1120 while in the configuration shownin FIG. 11C. In some embodiments, the medical device 1100 may besqueezed more than once during a medical procedure until the clampingarm 1120 is moved to a desirable position with respect to the receivingarm 1110, or a portion thereof (e.g., the coupling mechanism 1170 of thereceiving arm 1110). In some embodiments, the clamping arm 1120 may bemoved along direction 01 more than once and/or along direction O2 morethan once so that the clamping arm 1120 may be moved to a desirableposition with respect to the receiving arm 1110, or a portion thereof,during a medical procedure. In some embodiments, the handle 1115 may notbe coupled to the portion 1117 that has a portion disposed within theclamping arm 1120.

As shown in FIG. 11E, the medical device 1100 includes an indicatormember 1197, which is part of (e.g., integrated as part of) the portion1117. The indicator member 1197 can be configured to align with one ormore of indicators (not shown) (e.g., numbers, marks, detents)associated with (aligned along) the track 1130. In some embodiments, theindicator member 1197 and the indicators can collectively define anindicator mechanism. In some embodiments, the indicator member 1197 canindicate, for example, a distance between at least a portion of thereceiving arm 1110 (e.g., the coupling mechanism 1170) and at least aportion of the clamping arm 1120 (e.g., the track 1130, a distal portionof the guide 1150). In some embodiments, at least a portion of the track1130 may be translucent (for example, formed of a translucent material)so that the indicator member 1197 may be visible to a physician usingthe medical device 1100.

In some embodiments, the indicator member 1197 can also be configured tolimit movement of the sliding component 1140. For example, as shown inFIG. 11, the indicator member 1197 can be configured to prevent thesliding component 1140 from movement to a position beyond the indicatormember 1197. The sliding component 1140 has a protrusion 1198 (e.g., atab) that limits (e.g., stops) the movement of the sliding component1140 when the protrusion 1198 comes into contact with the indicatormember 1197.

In some embodiments, the indicator member 1197, when aligned with one ormore indicators along the track 1130, can indicate, for example, atarget position of the sliding component 1140 along the track 1130. Thetarget position can be a position at which at least a portion of theneedle 1160 is, for example, moved into or near the cavity 1172 of thecoupling mechanism 1170 so that the needle 1160 is coupled to at least aportion of an implant coupled to the coupling mechanism 1170. In someembodiments, the target position can be a position at which at least aportion of the needle 1160 comes into contact with at least a portion ofan implant coupled to the coupling mechanism 1170.

In some embodiments, the indicator member 1197 can be configured so thata distal portion of the needle 1160 will precisely move into the cavity1172 of the coupling mechanism 1170 of the receiving arm 1110. Forexample, the receiving arm 1110 can be moved towards the clamping arm1120 so that a distal end (a front portion) of the guide 1150 is adistance from the coupling mechanism 1170. The indicator member 1197 canbe configured to limit the movement of the sliding component so that theportion of the needle 1160 that is extended from (deployed from) thedistal end of the guide 1150 has a length that is approximately equalto, slightly greater than, or equal to the distance.

Although not shown in FIGS. 11A through 11E, the sliding component 1140can include a locking mechanism configured to releasably lock thesliding component 1140 in a position along the track 1130. In someembodiments, the sliding component 1140 can be releasably locked in anyposition along the track 1130 using the locking mechanism (e.g., aprotrusion, a tab). In some embodiments, the locking mechanism can bebiased so that the sliding component 1140 may not be moved along thetrack 1130 unless the locking mechanism is actuated. In other words, thelocking mechanism can be configured so that the locking mechanism can beactuated to release the locking mechanism so that the sliding component1140 may be slidably moved along the track 1130. In some embodiments,the locking mechanism can be biased so that the sliding component 1140may not be locked into a position along the track 1130 until actuatedusing the locking mechanism. In other words, the locking mechanism canbe configured so that the locking mechanism can be actuated to lock thesliding component 1140 along the track 1130.

Although not shown in FIGS. 11A through 11E, the medical device 1100 canhave a locking mechanism configured to lockably couple the clamping arm1120 with respect to the receiving arm 1110. In this embodiment, thelocking mechanism can be referred to as a ratchet mechanism. The lockingmechanism can be used to releasably lock the medical device 1100 in oneor more open configurations and/or one or more clamped configurations.In this embodiment, the locking mechanism can be configured toreleasably lock the clamping arm 1120 with respect to the receiving arm1110 as the clamping arm 1120 is moved towards, or over, at least aportion of the portion 1117 of the receiving arm 1110. For example, thelocking mechanism can be configured to releasably lock the clamping arm1120 with respect to the receiving arm 1110 as a physician squeezes themedical device 1100 so that the clamping arm 120 is moved towards, orover, at least a portion of the portion 1117 of the receiving arm 1110.

In the embodiment shown in at least FIG. 11A the needle 1160 of themedical device 1100 is configured to convey a fluid. The needle 1160 candefine a lumen that is configured to convey fluids to and/or from a bodyof a patient. As shown in FIG. 11A, the sliding component 1140 iscoupled to a syringe 1180 that has a plunger (also shown in FIGS. 11Bthrough 11E). The syringe 1180 is configured to deliver a fluid toand/or draw a fluid from the needle 1160.

In one general aspect, a medical device can include a receiving armconfigured to be coupled to at least a portion of an implant, a clampingarm having a proximal end coupled to the receiving arm and having atrack at a distal end of the clamping arm, and a sliding componentincluding a needle and configured to slidably move along the track ofthe clamping arm.

In some embodiments, the clamping arm can have an indicator configuredto represent a distance between at least a portion of the receiving armand at least a portion of the clamping arm. In some embodiments, thereceiving arm can have a coupling mechanism configured to be releasablycoupled to an implant. In some embodiments, the needle of the slidingcomponent can define a lumen therethrough, and the sliding component candefine an opening in fluid communication with the lumen defined by theneedle and configured to receive a fluid to be conveyed through thelumen.

In some embodiments, the track has a concave curvature with an innersurface of a concave portion facing toward the proximal end of theclamping arm. In some embodiments, the clamping arm can have a guidedefining a lumen, and the needle can be configured to slidably movewithin the lumen when the sliding component is slidably moved along thetrack of the clamping arm.

In some embodiments, the track can be configured to rotatably move aboutan axis towards the receiving arm from a first position with respect tothe receiving arm to a second position with respect to the receiving armwhen the clamping arm is moved towards the receiving arm. The slidingcomponent can be configured to slidably move along the track when thetrack is in the first position with respect to the receiving arm andconfigured to slidably move along the track when the track is in thesecond position with respect to the receiving arm.

In some embodiments, the needle is configured to slidably move through alumen and configured to move into at least a portion of the receivingarm. In some embodiments, the receiving arm can be configured to beinserted into a body of a patient after the receiving arm is coupled tothe at least the portion of the implant. In some embodiments, theclamping arm includes a side protrusion having a rough portion and asmooth portion.

In another general aspect, a medical device can include a receiving armconfigured to receive at least a portion of an implant, a clamping armcoupled to the receiving arm and configured to move a track such that adistance between the track and the receiving arm is decreased, and asliding component including a needle and configured to slidably movealong the track such that the needle is moved toward the receiving arm.

In some embodiments, the track is a first track, at least one of theclamping arm or the receiving arm is configured slidably move along asecond track such that the distance between the first track and thereceiving arm is decreased. In some embodiments, the sliding componentis configured to slidably move when the distance between the track andthe receiving arm is decreased. In some embodiments, the medical devicecan include a locking mechanism configured to removably lock theclamping arm in a position with respect to the receiving arm after thedistance between the track and the receiving arm has been decreased.

In some embodiments, the medical device can include an indicatormechanism configured to indicate a target position of the slidingcomponent so that at least a portion of the needle is in contact withthe implant when the sliding component is slidably moved along the trackto the target position. In some embodiments, the medical device caninclude a safety stop configured to limit movement of the slidingcomponent along the track.

In some embodiments, the needle coupled to the sliding component canhave a coupling mechanism configured to be coupled to the implant afterthe sliding component has been moved toward the receiving arm. Theclamping arm can be configured to move the track such that the distancebetween the track and the receiving arm is increased after the couplingmechanism of the needle has been coupled to the implant.

In some embodiments, the receiving arm is configured to be inserted intoa vaginal region of a patient before the clamping arm is moved. Theneedle can be configured to pierce a skin tissue of the patient when theneedle is moved toward the receiving arm. In some embodiments, theneedle can be configured to pierce a tissue of a patient and to becoupled to the implant as the needle is moved toward the receiving arm.The sliding component can be configured to slidably move along the trackaway from the receiving arm such that the implant is pulled through thetissue of the patient after the needle has been coupled to implant.

In some embodiments, the track can have a curvature facing in the samedirection as a curvature of a lumen of a guide of the clamping arm. Theneedle can be configured to slidably move within the lumen when thesliding component is slidably moved along the track of the clamping arm.In some embodiments, the sliding component can be configured to slidablymove along the track of the clamping arm until at least a portion of theneedle is disposed within the receiving arm.

In yet another general aspect, a method can include inserting at least aportion of a receiving arm of a medical device coupled to at least aportion of an implant into a body of a patient. The method can alsoinclude moving a sliding component along a track of a clamping arm suchthat a portion of a needle of the sliding component is moved into thebody of the patient and is coupled to the portion of the implant.

In some embodiments, the method can include moving, before the moving ofthe sliding component, the clamping arm toward the receiving arm. Insome embodiments, the moving can include moving the sliding component ina first direction. The method can include moving the sliding componentcoupled to the clamping arm in a second direction along the track of theclamping arm away from the receiving arm until the portion of theimplant coupled to the portion of the needle of the sliding component ismoved outside of the body of the patient.

In some embodiments, the moving can include moving the sliding componentin a first direction. The method can include inserting the portion ofthe implant into a coupling mechanism of the receiving arm of themedical device before the inserting the portion of the receiving arminto the body of the patient. The portion of the implant can be coupledto a coupling mechanism of the portion of the needle portion in responseto the moving of the sliding component. The method can include movingthe sliding component coupled to the clamping arm in a second directionalong the track of the clamping arm away from the receiving arm untilthe portion of the implant coupled to the portion of the needle of thesliding component is decoupled from the coupling mechanism of thereceiving arm.

While certain features of the described implementations have beenillustrated as described herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the scope of theembodiments.

What is claimed is:
 1. A medical device, comprising: a receiving armconfigured to be coupled to at least a portion of an implant; a clampingarm having a proximal end portion coupled to the receiving arm andhaving a track disposed at a distal end portion of the clamping arm; anda sliding component including a needle, the sliding component configuredto slidably move the needle along the track of the clamping arm, theclamping arm rotatably coupled to the receiving arm, the clamping armconfigured to rotate about an axis towards the receiving arm such that adistance between the track of the clamping arm and the receiving arm isdecreased, wherein the needle has a coupling mechanism configured to becoupled to the implant after the sliding component has been moved towardthe receiving arm, the track of the clamping arm configured to move suchthat the distance between the track and the receiving arm is increasedafter the coupling mechanism of the needle has been coupled to theimplant.
 2. The medical device of claim 1, wherein the clamping arm hasan indicator configured to represent a distance between at least aportion of the receiving arm and at least a portion of the clamping arm.3. The medical device of claim 1, wherein the receiving arm has acoupling mechanism configured to be releasably coupled to the implant.4. The medical device of claim 1, wherein the needle defines a lumentherethrough, and the sliding component defines an opening that is influid communication with the lumen defined by the needle and configuredto receive a fluid to be conveyed through the lumen.
 5. The medicaldevice of claim 1, wherein the track has a concave curvature with aninner surface of a concave portion facing toward the proximal endportion of the clamping arm.
 6. The medical device of claim 1, whereinthe clamping arm has a guide defining a lumen, the needle configured toslidably move within the lumen when the sliding component is slidablymoved along the track of the clamping arm.
 7. The medical device ofclaim 1, wherein the track is configured to rotatably move about theaxis towards the receiving arm from a first position with respect to thereceiving arm to a second position with respect to the receiving armwhen the clamping arm is rotated towards the receiving arm, the slidingcomponent is configured to slidably move along the track when the trackis in the first position with respect to the receiving arm andconfigured to slidably move along the track when the track is in thesecond position with respect to the receiving arm.
 8. The medical deviceof claim 1, wherein the clamping arm has a proximal end portion and adistal end portion, the proximal end portion of the clamping armrotatably coupled to the proximal end portion of the receiving arm via ahinge.
 9. The medical device of claim 1, wherein the receiving arm isconfigured to be inserted into a body of a patient after the receivingarm is coupled to the at least the portion of the implant.
 10. Themedical device of claim 1, wherein the clamping arm includes a sideprotrusion having a rough portion and a smooth portion.
 11. A medicaldevice, comprising: a receiving arm configured to receive at least aportion of an implant; a clamping arm rotatably coupled to the receivingarm, the clamping arm defining a track, the track configured to rotateabout an axis towards the receiving arm such that a distance between thetrack and the receiving arm is decreased; and a sliding componentincluding a needle, the sliding component configured to slidably movethe needle along the track such that the needle is moved toward thereceiving arm, wherein the needle has a coupling mechanism configured tobe coupled to the implant after the sliding component has been movedtoward the receiving arm, the clamping arm configured to move the tracksuch that the distance between the track and the receiving arm isincreased after the coupling mechanism of the needle has been coupled tothe implant.
 12. The medical device of claim 11, wherein the track is afirst track, at least one of the clamping arm or the receiving arm isconfigured to slidably move along a second track such that the distancebetween the first track and the receiving arm is decreased.
 13. Themedical device of claim 11, wherein the sliding component is configuredto slidably move when the distance between the track and the receivingarm is decreased.
 14. The medical device of claim 11, furthercomprising: a locking mechanism configured to removably lock theclamping arm in a position with respect to the receiving arm after thedistance between the track and the receiving arm has been decreased. 15.The medical device of claim 11, further comprising: an indicatormechanism configured to indicate a target position of the slidingcomponent so that at least a portion of the needle is in contact withthe implant when the sliding component is slidably moved along the trackto the target position.
 16. The medical device of claim 11, wherein thereceiving arm is configured to be inserted into a vaginal region of apatient before the clamping arm is moved, the needle configured topierce a skin tissue of the patient when the needle is moved toward thereceiving arm.
 17. The medical device of claim 11, wherein the needle isconfigured to pierce a tissue of a patient and to be coupled to theimplant as the needle is moved toward the receiving arm, the slidingcomponent configured to slidably move along the track away from thereceiving arm such that the implant is pulled through the tissue of thepatient after the needle has been coupled to implant.
 18. A method,comprising: inserting at least a portion of a receiving arm of a medicaldevice coupled to at least a portion of an implant into a body of apatient; moving a clamping arm rotatably coupled to the receiving armtowards the receiving arm, the clamping arm having a track; rotating thetrack about an axis towards the receiving arm when the clamping arm ismoved towards the receiving arm; moving a portion of a needle of asliding component into the body of the patient by moving the slidingcomponent coupled to the clamping arm in a first direction along thetrack of the clamping arm, the needle having a coupling mechanism thatcouples to the implant after the sliding component has been moved towardthe receiving arm; and increasing the distance between the track and thereceiving arm by moving the track of the clamping arm and after thecoupling mechanism of the needle has been coupled to the implant. 19.The method of claim 18, further comprising: moving the sliding componentin a second direction along the track away from the receiving arm untilthe portion of the implant coupled to the needle of the slidingcomponent is moved outside of the body of the patient.